MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ASSURITY RF DR; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number PM2240

Device Problems Pacemaker Found in Back-Up Mode (1440); Inappropriate or Unexpected Reset (2959); Data Problem (3196)

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

Event Date 11/20/2023

Event Type  Injury  

Event Description

It was reported that the patient presented in clinic for a follow up.Device interrogation revealed error message and unexpected reset on the pacemaker.The physician elected to explant and replace the pacemaker.The patient was in stable condition.

Manufacturer Narrative

Correction: h6 coding for pacemaker in back up.

Manufacturer Narrative

The reported event of device in backup mode was confirmed.As received, the device in backup operation with normal telemetry communication and output.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 at normal level.Hybrid circuitry was tested, indicating elevated current drain, consistent with moisture damage, resulting in the reported event.A manufacturing anomaly may have occurred, which resulted in the header bonding anomaly.The device is included in the assurity and endurity pacemakers header anomaly advisory issued by abbott on 15 march 2021.

• Brand Name: ASSURITY RF DR
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: 18298712
• MDR Text Key: 330111732
• Report Number: 2017865-2023-94355
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507073
• UDI-Public: 05414734507073
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2024

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: 04/30/2017
• Device Model Number: PM2240
• Device Lot Number: A000012873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/10/2023
• Supplement Dates Manufacturer Received: 12/12/2023; 01/15/2024
• Supplement Dates FDA Received: 12/13/2023; 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1530-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR
• Patient Sex: Male