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U.S. Department of Health and Human Services

Class 2 Device Recall Infinity DBS IPG with MDT header

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  Class 2 Device Recall Infinity DBS IPG with MDT header see related information
Date Initiated by Firm June 02, 2017
Create Date July 07, 2017
Recall Status1 Terminated 3 on August 24, 2022
Recall Number Z-2696-2017
Recall Event ID 77509
PMA Number P140009 
Product Classification Stimulator, electrical, implanted, for parkinsonian tremor - Product Code MHY
Product Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO

Product Usage:
The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG is conductive on all sides, which allows the IPG case (also called a can) to be used as an anode for monopolar stimulation. The IPG communicates wirelessly with system programmers and controllers, and IPGs are available in small and large sizes to accommodate different power needs.
Code Information AAD257.1 AAD302.1 AAP362.1 AAP375.1 AAP385.1 ALX096.1 ALX257.1 ALX258.1 ALY268.1 ALY409.1 ALY435.1 ALY632.1 ALY640.1 ALY763.1 ALY780.1 ALY788.1 ALZ034.1 ALZ042.1 ANT267.1 ANT731.1 ZV3966.1 ZW0230.1 ZW0376.1 ZW0429.1 ZW0458.1 ZW0498.1 ZW0544.1 ZW0545.1 ZW0567.1 ZW0570.1 ZW0576.1 ZW0590.1 ZX5511.1 ZY9379.1 ZY9394.1 ZY9398.1 ZY9405.1 ZY9413.1 ZY9433.1 ZY9530.1   
Recalling Firm/
Manufacturer		 St. Jude Medical, Inc.
6901 Preston Rd
Plano TX 75024-2508
For Additional Information Contact Justin Paquette
651-756-6293
Manufacturer Reason
for Recall		 The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
FDA Determined
Cause 2		 Device Design
Action The notification material is in the form of a Physician Letter and Patient letter which will be delivered to physicians and patients in the US. The physician mailing will be initiated June 2, 2017 for delivery on June 7-9, 2017. The physicians were provided with patient management recommendations, Step for the patient controller updates, and Clinician's Manual Revised Warning. The Patient mailings will begin the week of June 12, 2017 to allow for clinician notification and are expected to be delivered within 3-5 business days. The patient letter informs of them of the potential for the loss of therapy and the steps to receive the software upgrade.
Quantity in Commerce 40 units
Distribution US Nationwide 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 = MHY and Original Applicant = Abbott Medical
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