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

Model Number PM2272

Device Problems Signal Artifact/Noise (1036); Material Discolored (1170); Over-Sensing (1438); Communication or Transmission Problem (2896); Interrogation Problem (4017)

Patient Problem Arrhythmia (1721)

Event Date 11/14/2022

Event Type  Injury  

Event Description

It was reported that noise resulting in oversensing was noted on the device, the inductive telemetry of the device was slow, and the device was unable to be reprogrammed.During the replacement procedure, the device was pacing at the magnet response rate and did not change with reprogramming of the rate.The inappropriate magnet response was able to be addressed by programming to disable the magnet response.Abbott technical support was contacted and the device was found to have been stuck in magnet mode.Additionally, during the procedure, discoloration of the header was observed.The device was explanted and replaced to resolve the event.The patient was in stable condition.

Event Description

Related manufacturer report number 2017865-2022-47017.It was reported that right ventricular (rv) noise resulting in oversensing was noted, the inductive telemetry of the device was slow, and the device was unable to be reprogrammed.During the replacement procedure, the device was pacing at the magnet response rate and did not change with reprogramming of the rate.The inappropriate magnet response was able to be addressed by programming to disable the magnet response.Abbott technical support was contacted and the device was found to have been stuck in magnet mode.Additionally, during the procedure, discoloration of the header was observed.The device was explanted and replaced and the rv lead was capped and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

The reported events of inability to interrogate and transmission issues were not confirmed.Reported event of inappropriate magnet response and header discoloration was confirmed.Oversensing test could not be performed due to device turned into bvvi during analysis, which could not be recovered.The device was received with normal telemetry communication and anomalous 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 ranges.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 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: 15852273
• MDR Text Key: 304188490
• Report Number: 2017865-2022-46483
• 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,Followup
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: PM2272
• Device Catalogue Number: PM2272
• Device Lot Number: P000095213
• 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: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2019
• 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