MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) UNIFY QUADRA CRT-D, OUS MODEL, DF4COMP; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3251-40Q

Device Problems Premature Discharge of Battery (1057); Communication or Transmission Problem (2896); Interrogation Problem (4017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2021

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that the implantable cardiac defibrillator was not connected to the patient's home monitoring system for more than thirty days.During a return check in clinic it was noted that a battery performance alert (bpa) advisory as well as an elective replacement indicator (eri) was observed on the same day (b)(6) 2021.The physician questioned why the alerts were not picked by home monitoring.The device was awaiting explant.The patient was stable.

Manufacturer Narrative

Premature battery depletion was confirmed by analysis.A device evaluation was performed, and no sources of high current were noted.The cause of the premature battery depletion was consistent with li cluster formation.From these analyses, in the absence of high current draw, it is probable that the premature battery depletion was caused by a lithium cluster induced short circuit.Li clusters are a known depletion mechanism for these advisory products that has been investigated and associated with a field action in october 2016.Per merlin.Net, several session records were captured every month up to nov 1, 2020.The next available session record occurred on mar 19, 2021.There was a gap from nov 2020 to mar 2021.The issue could be a network connectivity issue though the cause was not determined.

Event Description

New information received notes there was a connectivity issue between the device and the home monitoring system for a month, followed by the device reaching the elective replacement indicator (eri) and a battery performance alert was observed at the same time.The device was explanted on march 26, 2021.The patient was discharged the next day.

• Brand Name: UNIFY QUADRA CRT-D, OUS MODEL, DF4COMP
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11624389
• MDR Text Key: 244161131
• Report Number: 2017865-2021-13868
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: CD3251-40Q
• Device Lot Number: 4203908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0004-2018; Z-0117-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention