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U.S. Department of Health and Human Services

Class 2 Device Recall Renamic and ICS 3000

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 Class 2 Device Recall Renamic and ICS 3000see related information
Date Initiated by FirmJune 30, 2015
Date PostedAugust 13, 2015
Recall Status1 Terminated 3 on December 24, 2015
Recall NumberZ-2376-2015
Recall Event ID 71658
PMA NumberP950037S148 
Product Classification Pacemaker/icd/crt non-implanted components - Product Code rce
ProductPSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). Allows physicians to program devices to pace exclusively in the left ventricle.
Code Information Affected Product Part Numbers: 394229, 400335, 403222, 406797, 408849 
Recalling Firm/
Manufacturer		 BIOTRONIK, Inc.
6024 Jean Rd
Lake Oswego OR 97035-5571
For Additional Information Contact
800-284-6689
Manufacturer Reason
for Recall		Ventricular packing: LV software programming versions for BIOTRONIK CRT-P and CRT-D devices are recalled because they are not approved for use in the US.
FDA Determined
Cause 2		Software Manufacturing/Software Deployment
ActionBIOTRONIK sent the Important Product Information letter and the Acknowledgement of Important Product Information Form, dated June 20, 2015, to affected physicians with the following recommendations: -Review programming settings for your patients with CRT-P or CRT-D devices. -If you have a patient with a device programmed to Ventricular pacing: LV, arrange to have the patients device reprogrammed to an appropriate approved mode (i.e. "Ventricular pacing: RV" or "Ventricular pacing: BiV"). -Physicians are requested to sign the Acknowledgement of Important Product Information Form and immediately fax to 800-913-6993 or email to UScompliance@biotronik.com. BIOTRONIK'S representative will update your programmer with approved 1502.U programmer software. Following this update, the Ventricular pacing: LV feature will no longer be available. However, a device previously programmed with "Ventricular pacing: LV will remain programmed in this mode unless and until the pacing mode setting is changed. If you have any questions concerning this Important Product Information, please contact the BIOTRONIK Technical Services Department: Telephone: 1-(800) 284-6689 (24-hour service)
Quantity in Commerce768 units (software)
DistributionNationwide Distribution.
Total Product Life CycleTPLC 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.
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