MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ALLURE QUADRA RF CRT-P; NO MATCH

Model Number PM3242

Device Problems Premature Discharge of Battery (1057); Failure to Capture (1081); Failure to Interrogate (1332)

Patient Problem Fatigue (1849)

Event Date 08/24/2023

Event Type  Injury  

Event Description

It was reported that the patient presented during clinical follow-up.In clinic, the pacemaker presented with loss of capture, failure to interrogate, and no magnet response.Previous interrogation noted that the device exhibited premature battery depletion and it was noted that the patient felt fatigue since (b)(6) of 2023.The reported device was explanted.The patient's condition was unknown.

Manufacturer Narrative

The reported events of failure to capture, inability to interrogate, no magnet response and premature depletion were confirmed.As received, the device telemetry and output were not available.A device history record (dhr) review was performed and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.Visual inspection of the header attachment area detected a bonding anomaly.A device hermeticity breach was observed, consistent with feedthrough damage as a result of fluid intrusion between the header and case, and subsequent fluid ingress to the internal electronics.The device was cut open to enable further testing and battery was found depleted.Hybrid circuitry was tested, indicating elevated current drain, consistent with moisture damage, depleting the battery prematurely, and resulting in the reported events.A manufacturing anomaly may have occurred, which resulted in the header bonding anomaly.

Event Description

Additional information received noted that the pacemaker was explanted on (b)(6)2023.

• Brand Name: ALLURE QUADRA RF CRT-P
• Type of Device: NO MATCH
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17737283
• MDR Text Key: 323289574
• Report Number: 2017865-2023-42839
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734507912
• UDI-Public: 05414734507912
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P030035
• 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,Followup
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: PM3242
• Device Lot Number: A000042633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2017
• 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