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U.S. Department of Health and Human Services

Class 2 Device Recall Platinium Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator

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  Class 2 Device Recall Platinium Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator see related information
Date Initiated by Firm July 09, 2018
Create Date August 15, 2018
Recall Status1 Completed
Recall Number Z-2824-2018
Recall Event ID 80636
PMA Number P060027S079 
Product Classification Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
Product Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Code Information Model TDF033U, UDI GTIN 08031527015538   Serial Numbers: 619DK0FB, 618DK003, 619DK0C0, 622DK03B, 622DK12A, 624DK070, 624DK12F, 619DK021, 627DK0B0, 618DK0A4, 619DK097, 620DK065, 619DK09B, 619DK05F, 619DK088, 619DK0CC
Recalling Firm/
Manufacturer		 Sorin CRM SAS
Cvk
4, avenue Reaumur
Clamart Cedex France
Manufacturer Reason
for Recall		 Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabilities. The device then cannot identify an arrhythmia that would require defibrillation shock therapy.
FDA Determined
Cause 2		 Component design/selection
Action On 07/09/2018, Urgent Field Safety Notices were mailed via certified postal service to physicians informing them about the removal of the non implanted Platinium devices that may present with this hardware failure and providing recommendations for managing implanted patients, which includes patient follow-up one month after discharge, and then every three months until the device nears the replacement date. Follow-up should include checking for battery status and system warnings. The firm recommends that patients be enrolled in remote monitoring. Physicians were instructed to fill out Customer Reply forms and ensure that all personnel involved in the management of patients implanted with affected devices are aware of the information outlined in the notice. For further assistance the firm provided 877-663-7674.
Quantity in Commerce 16
Distribution US distribution to: NJ, AZ, MS, OK, LA, PA, FL, MI, IL, and MS
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.
PMA Database PMAs with Product Code = NIK and Original Applicant = MicroPort CRM USA Inc.
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