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U.S. Department of Health and Human Services

Class 3 Device Recall iCon Patient Programmer

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  Class 3 Device Recall iCon Patient Programmer see related information
Date Initiated by Firm May 12, 2008
Date Posted September 20, 2008
Recall Status1 Terminated 3 on November 21, 2008
Recall Number Z-2322-2008
Recall Event ID 48752
PMA Number P970004S032 
Product Classification Stimulator, electrical, implantable, for incontinence - Product Code EZW
Product Medtronic iCon Patient Programmer, model 3037. The Patient programmer is a hand held, battery operated, microcontroller based device for use by patients to control and monitor external and implantable devices. The minimum amount of control involves the ability to turn therapy ON or OFF; maximal control allows the patient to select from different therapies and adjust the parameters with in the set therapy limits.
Code Information serial numbers: NJD058707N, NJD062024N, NJD063259N, and NJD063324N
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
800 53rd Ave NE
PO Box 1250
Minneapolis MN 55440-1250
For Additional Information Contact
763-514-5174
Manufacturer Reason
for Recall		 Medtronic is retrieving four (4) patient programmers that were not properly loaded with application software. The application software is needed for a patient programmer to synchronize and bond with a neurostimulation device. Without this functionality a patient programmer is not useable and can not communicate with a neurostimulation device.
FDA Determined
Cause 2		 Process control
Action A letter was sent to each account telling them of the issue and to let them know that Medtronic is retrieving the affected devices. Medtronic Reps were to visit affected accounts to notify them of the recall, locate the affected device and return it. Rep is to complete the reply card and fax to Medtronic Neuromodulation. If you have questions, contact your Medtronic representative or Medtronic Neuromodulation Technical Services at 1-800-707-0933.
Quantity in Commerce 2
Distribution GA, MO, NC, TX no OUS distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = EZW and Original Applicant = MEDTRONIC NEUROMODULATION
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