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

Model Number PM2272

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Further information was requested but not received.

Event Description

Related manufacturer reference number: 2017865-2022-51070, 2017865-2022-51071.It was reported that the patient presented with bacteremia, endocarditis and vegetation during follow-up in clinic.Cultures indicated the patient had a methicillin-susceptible staphylococcus aureus (mssa) infection and antibiotics were provided.The physician explanted the system ¿ pacemaker, right atrial lead and right ventricular lead.The patient was in stable condition.

Manufacturer Narrative

The device was returned due to infection.A device history record (dhr) review was performed and review of the sterilization records confirmed normal sterilization cycles for the products.All required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.The product was returned and visual inspection was normal.The cause of infection could not be traced to the device. a malfunction based on analysis was found as received, the device output and telemetry communication were normal.Capture test was performed on the device and it was able to capture within the product specification.Visual inspection of the header attachment area detected a bonding anomaly.The device was cut open to enable further testing and the battery was found in normal range.Hybrid circuitry was tested, and the results indicated normal current drain.A manufacturing anomaly may have occurred, which resulted in the header bonding anomaly.The device is included in the assurity and endurity pacemakers header anomaly advisory issued by abbott on 15 march 2021.

• 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: 16076245
• MDR Text Key: 306405583
• Report Number: 2017865-2022-51069
• 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: Health Professional,User Facility
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/26/2023

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: 10/31/2020
• Device Model Number: PM2272
• Device Catalogue Number: PM2272
• Device Lot Number: A000077877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 02/22/2023
• Supplement Dates FDA Received: 02/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1530-2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male