MAUDE Adverse Event Report: ABBOTT ASSURITY MRI; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number PM2272

Device Problems Failure to Interrogate (1332); Pacemaker Found in Back-Up Mode (1440); Inappropriate or Unexpected Reset (2959)

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

Event Date 10/26/2023

Event Type  Injury  

Event Description

It was reported that the device was found in backup mode and could not be interrogated.The device was explanted and replaced to resolve the event.The patient was stable and there were no adverse consequences.

Manufacturer Narrative

The reported events of inappropriate or unexpected reset and inability to interrogate were confirmed.The device was received with no output and no telemetry.Visual inspection of the header attachment area detected an anomaly between the pre-molded header and titanium case.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 elevated current drain, consistent with moisture damage, resulting in the reported events.A manufacturing process anomaly may have occurred, which resulted in the header bonding anomaly.The device is included in the zenex, assurity, endurity laser adhesion preparation advisory issued by abbott on(b)(6) 2022 for a subset of devices distributed and implanted outside of the united states.

• Brand Name: ASSURITY MRI
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): ABBOTT; 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: 18111756
• MDR Text Key: 327866310
• Report Number: 2017865-2023-51749
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509589
• UDI-Public: 05414734509589
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P140033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

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: 04/30/2021
• Device Model Number: PM2272
• Device Lot Number: P000091671
• 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: Not provided
• Initial Date FDA Received: 11/10/2023
• Supplement Dates Manufacturer Received: 01/12/2024
• Supplement Dates FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2019
• 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