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); Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Fatigue (1849); Discomfort (2330)

Event Date 09/04/2023

Event Type  Injury  

Event Description

It was reported that the patient presented to the emergency room with symptoms of extra cardiac stimulation and fatigue.The pacemaker (pm) was found to be in backup mode.The physician elected to explant and replace the pm.The patient was discharged following the procedure.

Manufacturer Narrative

The reported events of device were in backup mode and extra cardiac simulation were confirmed.The device was received with normal telemetry communication and in backup mode.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.The device met specifications prior to leaving abbott manufacturing facilities.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 elective-replacement level.Hybrid circuitry was tested, indicating high 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.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: 17803867
• MDR Text Key: 324106036
• Report Number: 2017865-2023-46777
• Device Sequence Number: 1
• Product Code: NVZ
• 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
• Report Date: 11/17/2023

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: 09/30/2017
• Device Model Number: PM2240
• Device Lot Number: A000019709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/04/2023
• Initial Date FDA Received: 09/22/2023
• Supplement Dates Manufacturer Received: 10/27/2023
• Supplement Dates FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2016
• 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
• Treatment: TENDRIL RA LEAD.; TENDRIL RV LEAD.
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male