MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ASSURITY MRI; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM2272

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 12/15/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned without identified device or use problem.A malfunction based on analysis was found.As received, the device output and telemetry communication were normal.Visual inspection of the header attachment area detected a bonding anomaly.A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.The device was tested for a hermeticity breach which was not observed.The device was cut open to enable further testing and battery was found in normal range.The hybrid circuitry was tested, and the results indicated normal current drain.A manufacturing anomaly may have occurred, which resulted in the header bonding anomaly.

Event Description

This report is to advise of an event observed during analysis.

• Brand Name: ASSURITY MRI
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 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: 16043149
• MDR Text Key: 306563739
• Report Number: 2017865-2022-50688
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2021
• Device Model Number: PM2272
• Device Catalogue Number: PM2272
• Device Lot Number: A000088947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2022
• Initial Date FDA Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2019
• 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