MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ALLURE QUADRA RF CRT-P; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM3242

Device Problem Premature Discharge of Battery (1057)

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

Event Date 12/01/2021

Event Type  Injury  

Event Description

It was reported that a patient presented for a generator replacement.The physician was concerned about the estimated longevity of the pacemaker as the device reached elective replacement indicator earlier than expected.The left ventricular lead also exhibited high capture thresholds.The pacemaker was explanted, meanwhile there were no plans to revise the lead as it was used for the next system.The patient was stable.Related manufacturer reference number: 2017865-2021-40511.

Manufacturer Narrative

The reported event of premature battery depletion was not confirmed.A malfunction based on analysis was found.As received, the device output and telemetry communication were normal.Visual inspection of the header attachment area detected a bonding anomaly.The device was tested for a hermeticity breach which was not observed.The device was cut open to enable further testing and the battery was found in elective replacement range, due to normal battery usage.The hybrid circuitry was tested, and the results indicated normal current drain.A manufacturing anomaly may have occurred, which resulted in the header bonding anomaly.

• Brand Name: ALLURE QUADRA RF CRT-P
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13122475
• MDR Text Key: 283141984
• Report Number: 2017865-2021-40510
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734507912
• UDI-Public: 05414734507912
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: PM3242
• Device Catalogue Number: PM3242
• Device Lot Number: 4891602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2014
• 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
• Treatment: TENDRIL
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Race: White