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

Model Number PM2272

Device Problems Premature Discharge of Battery (1057); Over-Sensing (1438); Capturing Problem (2891)

Patient Problems Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/03/2024

Event Type  Injury  

Event Description

It was reported, the patient presented in clinic due to shortness of breath.Upon interrogation a high capture threshold, cross talk and an epi alert was observed on the device.A device exchange is anticipated however, has not yet been performed.The patient was stable.

Event Description

Additional information was received indicating the device was explanted.The patient was stable.

Manufacturer Narrative

The reported events of premature battery discharge, inadequate capture and crosstalk were confirmed.The device was received with normal output and normal telemetry.Device image analysis and functional device testing show elevated device current after the explant.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 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 (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): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18511076
• MDR Text Key: 332867465
• Report Number: 2017865-2024-01140
• 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: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: PM2272
• Device Lot Number: P000103187
• 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: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2020
• 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