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

Model Number PM1240

Device Problems Failure to Capture (1081); Pacing Problem (1439); No Pacing (3268)

Patient Problems Arrhythmia (1721); Syncope/Fainting (4411)

Event Date 10/29/2022

Event Type  Injury  

Event Description

It was reported that no pace and capture was observed on the ems ekg strip of heart rate of 33bpm and a need to place a temporary pacemaker was noted.The patient had syncopal episodes resulting in passing out, no device related.The device was explanted and replaced the patient was stable during and post procedure.The device is subject to the assurity and endurity pacemakers header anomaly advisory issued by abbott on (b)(6) 2021.

Manufacturer Narrative

The reported event of pacing problem and failure to capture could not be confirmed.The device was received with normal telemetry and output.Capture tests were performed, which indicated normal device functionality.Longevity assessment found the device was operating above the elective replacement indicator (eri) voltage with appropriate remaining longevity.The device was received with normal telemetry and output.Visual inspection of the header attachment area detected an 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 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 SR RF
• 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: 15788467
• MDR Text Key: 303559378
• Report Number: 2017865-2022-44849
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507066
• UDI-Public: 05414734507066
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: PM1240
• Device Catalogue Number: PM1240
• Device Lot Number: A000021888
• 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: 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2016
• 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
• Treatment: MED-5076
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 57 KG