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

Model Number PM2272

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2022

Event Type  Injury  

Event Description

It was reported the device is subject to the assurity and endurity pacemakers header anomaly advisory issued by abbott on 15 march 2021.Explant of the device was performed on (b)(6) 2022 and the patient was in stable.

Manufacturer Narrative

Correction: section h6 - heath effect clinical code should be "discomfort" and adding one more medical device problem code of "migration or expulsion of device".

Manufacturer Narrative

The device with battery voltage above elective replacement level was returned for analysis.No anomaly found on the header.Longevity assessment and electrical test including thermal and mechanical stress were normal with no any anomalies found.

• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13429746
• MDR Text Key: 284962069
• Report Number: 2017865-2022-02459
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509589
• UDI-Public: 05414734509589
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2022

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: 07/31/2020
• Device Model Number: PM2272
• Device Catalogue Number: PM2272
• Device Lot Number: A000072709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2022
• Initial Date FDA Received: 02/02/2022
• Supplement Dates Manufacturer Received: 02/17/2022; 02/28/2022
• Supplement Dates FDA Received: 02/18/2022; 03/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2019
• 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
• Treatment: TENDRIL ST; TENDRIL ST
• Patient Outcome(s): Required Intervention
• Patient Age: 93 YR
• Patient Sex: Female
• Patient Weight: 91 KG