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

Model Number PM2272

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Wireless Communication Problem (3283)

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

Event Date 07/27/2022

Event Type  Injury  

Event Description

It was reported that the device was explanted and replaced as it is subject to the zenex, assurity, endurity laser adhesion preparation field safety correction action which applies to a subset of devices distributed and implanted outside of the united states.It was also observed the device was in lockout.The patient was in stable condition.Further information was requested but is not yet available.

Manufacturer Narrative

The reported event of wireless communication issue was confirmed.The device was received with no telemetry communication and no output.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 in normal range.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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15162881
• MDR Text Key: 297216631
• Report Number: 2017865-2022-16699
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509589
• UDI-Public: 05414734509589
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/04/2022

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: 07/31/2021
• Device Model Number: PM2272
• Device Catalogue Number: PM2272
• Device Lot Number: P000097196
• 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: 07/28/2022
• Initial Date FDA Received: 08/04/2022
• Supplement Dates Manufacturer Received: 10/18/2022
• Supplement Dates FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2020
• 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