MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3231-40

Device Problem Premature Discharge of Battery (1057)

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

Event Date 07/17/2018

Event Type  Injury  

Event Description

It was reported that the implantable cardioverter defibrillator exhibited premature battery depletion and reached end of life indicator.The device was explanted and replaced.No further information was reported.

Manufacturer Narrative

The reported event of premature battery depletion could not be confirmed.Interrogation of the device revealed the device was at eri when received.A longevity calculation was performed and found the battery depletion was normal based on the device usage.Based on this information, there was no evidence of premature depletion.

• Brand Name: UNIFY CRT-D
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8192729
• MDR Text Key: 131298436
• Report Number: 2017865-2018-19480
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734504362
• UDI-Public: 05414734504362
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

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: 11/30/2012
• Device Model Number: CD3231-40
• Device Catalogue Number: CD3231-40
• Device Lot Number: 3399253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 12/21/2018
• Supplement Dates Manufacturer Received: 03/14/2019
• Supplement Dates FDA Received: 03/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2011
• 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