have a look at the REFERENCES:
1. "Eliminate Whisker Growth on Contacts by Using a Tin Alloy
Plate," R.P. Diehl & N.A. Cifaldi, Insulation/Circuits, pp. 37-39, Apr.
1976.
2. "How to Avoid Metallic Growth Problems on Electronic Hardware,"
Tech Report IPC-TR-476, The Institute for Interconnecting & Packaging
Electronic Circuits (IPC), 1977.
3. "Identification of Fused Tin Coatings on Integrated Circuit
Device Leads," W.G. Bader, Plating & Surface Finishing, pp. 56-57, Aug.
1977.
4. "Spontaneous Growth of Whiskers on Tin Coatings: 20 Years of
Observation," S.C. Britton, Trans. Inst. of Metal Finishing, Vol 52, pp.
95-102, Apr. 1974.
5. "Tin Whiskers: Causes & Remedies," N.A.J. Sabbagh & H.J.
McQueen, Metal Finishing, pp. 27-31, Mar. 1975.
has anybody done anything relevent since 1977?
-----Original Message-----
From: TechNet [mailto:[log in to unmask]] On Behalf Of Bob Landman
Sent: Thursday, February 18, 2010 2:43 PM
To: [log in to unmask]
Subject: Re: [TN] Pace maker recall URL
Actually, we don't know what caused the "separation of wires". Where
did the wires separate and why? A connector problem? A solder problem?
The FDA document is useless.
This is interesting http://www.yourlawyer.com/articles/read/16568
"Medtronic said it has received reports of two patient deaths where it
is possible, but unclear, whether a wire separation issue may have been
a factor."
The Medtronic document is actually more revealing
http://www.medtronic.com/crm/performance/advisories/sigma-nov2005.html
Sigma Implantable Pulse Generators
Original Date of Advisory: November 2005
Potential Separation of Interconnect Wires
Product
A specific subset of Sigma series pacemakers may fail due to separation
of interconnect wires from the hybrid circuit. Specific model and serial
numbers of affected devices are available online
at:http://SigmaSNList.medtronic.com.
Advisory
This subset of Sigma series pacemakers that may fail due to separation
of interconnect wires from the hybrid circuit may present clinically as
loss of rate response, premature battery depletion, intermittent or
total loss of telemetry, or no output.
Separation of redundant interconnect wires has been observed on hybrid
terminal blocks. Device failure occurs only where both interconnect
wires separate from a hybrid terminal block. In October 2005, testing
and analysis identified the root cause of these failures and the
affected population. Hybrid circuits used in this subset of devices were
cleaned during manufacturing with a particular cleaning solvent that
could potentially reduce the strength of the interconnect wire bond over
time.
No provocative testing can predict which devices may fail.
Patient Management Recommendations
Recommendation for the management of patients who have pacemakers
affected by this advisory were changed in May 2009. Current
recommendations are:
We realize that each patient requires unique clinical consideration and
we support your judgment in caring for your patients. After consultation
with Medtronic's Independent Physician Quality Panel, Medtronic offers
the following recommendations for patients in the 2005 Sigma advisory:
* Physicians should advise their patients to seek medical attention
immediately if they experience symptoms (e.g., fainting or
lightheadedness).
* Physicians should consider device replacement for patients who are
both pacemaker dependent and who have been implanted with a device in
the affected subsets. Medtronic will offer a supplemental device
warranty if the device is not already at elective replacement time.
* Physicians should continue routine follow-up in accordance with
standard practice for those patients who are not pacemaker dependent.
Status Update
As of July 31, 2009, 328 devices out of approximately 40,000 devices
worldwide have been confirmed as having experienced interconnect wire
separation. Seventy-five (75) of these devices were returned from the
United States.
One hundred ninety-three (193) of the 328 devices (0.46%) were returned
with information indicating a problem with the patient's pacing system
prior to explant. The remaining 135 devices (0.32%) were returned with
no information indicating a potential malfunction while implanted or
with insufficient information to determine the state of the device at
explant. Lacking definite information indicating proper operation until
explant, these devices are conservatively categorized as having
experienced interconnect wire separation while implanted.
Our original modeling predicted a failure rate from 0.17% to 0.30% over
the remaining lifetime of these pacemakers. However, updated modeling
now predicts a failure rate of 3.9% over the remaining device life.
Out of the initial advisory population of 40,000 worldwide,
approximately 13,100 remain implanted. Approximately 3,100 of these are
in the United States.
=====================
Bob Landman
H&L Instruments, LLC
-----Original Message-----
From: TechNet [mailto:[log in to unmask]] On Behalf Of Reliability
Resources
Sent: Thursday, February 18, 2010 12:00 PM
To: [log in to unmask]
Subject: Re: [TN] Pace maker recall URL
This recall was not caused by tin whiskers.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/List
ofRe
calls/ucm166344.htm
Reason for Recall: The Kappa and Sigma pacemakers in these identified
series may fail due to a separation of wires that connect the electronic
circuit to other pacemaker components, such as the battery.
Clayton Bonn
Reliability Resources
Ph: 714-612-9359
e-mail:[log in to unmask]
www.reliability-resources.com
-----Original Message-----
From: TechNet [mailto:[log in to unmask]] On Behalf Of Ahne Oosterhof
Sent: Wednesday, February 17, 2010 1:47 PM
To: [log in to unmask]
Subject: Re: [TN] Pace maker recall URL
I like this sentence in that FDA announcement under conclusions:
Untreated tin coating should never be used in conjunction with
electronic circuitry.
Especially the generalization of the statement!
That page was last updated 30Apr09.
Ahne.
-----Original Message-----
From: TechNet [mailto:[log in to unmask]] On Behalf Of Brooks, Bill
Sent: Wednesday, February 17, 2010 12:42
To: [log in to unmask]
Subject: Re: [TN] Pace maker recall URL
http://www.fda.gov/ICECI/Inspections/InspectionGuides/InspectionTechnica
lGuides/ucm072921.htm
Check that link out...
Bill Brooks | Datron World Communications, Inc.
PCB Designer/Engineer | Office: 760-602-7004| Fax: 760-597-3777 |
[log in to unmask] 1808 Aston Avenue, Suite 230, Carlsbad, CA 92008 |
www.dtwc.com
Performance You Require. Value You ExpectTM
-----Original Message-----
From: TechNet [mailto:[log in to unmask]] On Behalf Of Roberts, Jon (SA-1)
Sent: Wednesday, February 17, 2010 12:17 PM
To: [log in to unmask]
Subject: Re: [TN] Pace maker recall URL
I did not readily see the root cause on any of the Medtronic recalls. So
where is the actual report stated it was whiskers? I may have missed
it, Thanks, Jon
-----Original Message-----
From: TechNet [mailto:[log in to unmask]] On Behalf Of John Burke
Sent: Wednesday, February 17, 2010 1:37 PM
To: [log in to unmask]
Subject: Re: [TN] Pace maker recall URL
Here you go:
6) FDA forced Medtronic to recall their implanted cardiac
defibrilators (from patients bodies) when whiskers shorted the devices.
http://www.fda.gov/ora/inspect_ref/itg/itg42.html
John Burke
(408) 515 4992
-----Original Message-----
From: TechNet [mailto:[log in to unmask]] On Behalf Of Victor Hernandez
Sent: Wednesday, February 17, 2010 9:19 AM
To: [log in to unmask]
Subject: [TN] Pace maker recall URL
Fellow TechNetters:
A few weeks back on of the subscriber share health information about
a
recall pace maker which I found very interesting. How, I am not able
to
locate that link now that I have a need for it. That subscriber share
that URL site once again.
In advance I thank you for your timely response in this matter.
Victor,
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