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

Model Number PM3262

Device Problems Failure to Interrogate (1332); No Pacing (3268)

Patient Problem Arrhythmia (1721)

Event Date 01/28/2024

Event Type  Injury  

Event Description

It was reported, that the patient presented in emergency room, due to an arrhythmia.Device interrogation revealed, failure to capture, failure to interrogate with no magnet and no radiofrequency.And no low voltage output on the pacemaker.The physician elected to explant and replace the pacemaker.The patient was in stable condition.

Manufacturer Narrative

The reported events of no magnet response, no rf telemetry and no output were confirmed.As received, the device had no telemetry communication and no output.Visual inspection of the header attachment area detected a bonding anomaly.A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.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, resulting in high current drain, consistent with moisture damage, depleting the battery and resulting in the reported events.A manufacturing anomaly may have occurred, which resulted in the header bonding anomaly.

Event Description

Correction: it was reported that the patient presented in emergency room due to a bradycardic arrhythmia.Device interrogation revealed failure to interrogate with both radiofrequency and inductive telemetry, no magnet response, and no low voltage output on the pacemaker.The physician elected to explant and replace the pacemaker.The patient was in stable condition.

• Brand Name: QUADRA ALLURE MP 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: 18727920
• MDR Text Key: 335691801
• Report Number: 2017865-2024-32934
• Device Sequence Number: 1
• Product Code: NIK
• 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: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: PM3262
• Device Lot Number: A000056304
• 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: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2017
• 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
• Treatment: 1458Q/86; LPA1200M/52; LPA1200M/58
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male