MAUDE Adverse Event Report: ABBOTT ASSURITY MRI; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM2272

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

Patient Problems Arrhythmia (1721); Fatigue (1849)

Event Date 12/16/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced bradycardia and fatigue.The device could not be interrogated and was not pacing.The device was explanted and replaced to resolve the event.The patient was stable following the procedure and there were no adverse consequences.

Manufacturer Narrative

The reported event of inability to interrogate was confirmed.The reported event of inability to pace was not confirmed.The device was received with intermittent telemetry communication and normal output.Visual inspection of the header attachment area detected an anomaly between the epoxy header and titanium case.The device was cut open to enable further testing and the battery was found at normal levels.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, and the 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 zenex, assurity, endurity laser adhesion preparation advisory issued by abbott on 20 july 2022 for a subset of devices distributed and implanted outside of the united states.

• Brand Name: ASSURITY MRI
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16039598
• MDR Text Key: 306061013
• Report Number: 2017865-2022-50546
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: PM2272
• Device Catalogue Number: PM2272
• Device Lot Number: A000023386
• 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: 02/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2016
• 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