MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD PROMOTE RF CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number 3213-36

Device Problems Premature Discharge of Battery (1057); No Device Output (1435)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2011

Event Type  Injury  

Event Description

It was reported that the device exhibited a prematurely depleted battery and no output.The device was explanted and replaced.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.This historical complaint is being filed as part of a retrospective review of complaint files in response to a recent fda inspection.There is no change to the actual performance of the product and this report only represents an enhancement to the reporting criteria going forward.Longevity estimations were performed and the device did not meet the expected longevity based on device usage.No high current drain sources were found.The battery was destructively analyzed which found no sources of shorting.The cause of premature battery depletion could not be determined.

• Brand Name: PROMOTE RF CRT-D
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view court; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 3730117
• MDR Text Key: 16776217
• Report Number: 2938836-2014-08951
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2008
• Device Model Number: 3213-36
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2011
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2011
• Initial Date FDA Received: 04/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention