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

Model Number PM2240

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

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

Event Date 10/21/2022

Event Type  Injury  

Event Description

It was reported that the pacemaker exhibited inability to interrogate and loss of pacing.The pacemaker was explanted and replaced.Patient was stable.

Manufacturer Narrative

The reported events of inability to interrogate and inability to pace were confirmed.The device was received with no telemetry communication and no output.Visual inspection of the header attachment area detected an 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.The device was cut open to enable further testing and the battery was found depleted.Feedthrough leak test was performed, indicating a device hermeticity breach.This is consistent with feedthrough damage as a result of fluid intrusion between the header and case, and subsequent fluid ingress to internal electronics.Hybrid circuitry was tested by connecting to an external power source.Test results indicated normal current drain.A manufacturing process 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 (b)(6) 2021.

• Brand Name: ASSURITY RF DR
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15774243
• MDR Text Key: 303538532
• Report Number: 2017865-2022-44963
• 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: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/24/2023

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: 08/31/2018
• Device Model Number: PM2240
• Device Catalogue Number: PM2240
• Device Lot Number: A000036144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/21/2022
• Initial Date FDA Received: 11/10/2022
• Supplement Dates Manufacturer Received: 02/20/2023
• Supplement Dates FDA Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2017
• 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: RIGHT ATRIAL LEAD; RIGHT VENTRICLE LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male