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

Model Number PM2240

Device Problems Failure to Interrogate (1332); Adverse Event Without Identified Device or Use Problem (2993); No Pacing (3268)

Patient Problem Arrhythmia (1721)

Event Date 11/06/2022

Event Type  Injury  

Manufacturer Narrative

The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that a patient presented to the emergency room after experiencing a bradycardia, where it was reported that the device exhibited a complete loss of telemetry.The device was explanted and replaced.The patient was stable throughout.

Event Description

New information notes that there was a loss of pacing output on the patient's pacemaker.

Manufacturer Narrative

The device was returned to inability to interrogate and no pacing.The reported events of inability to interrogate and pacing issues were confirmed.A malfunction based on analysis was found.As received, the device had no telemetry communication and no output.A device history record (dhr) review was performed and 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.Visual inspection of the header attachment area detected a bonding anomaly.A device hermeticity breach was observed, consistent with feedthrough damage as a result of fluid intrusion between the header and case, and subsequent fluid ingress to the internal electronics.The device was cut open to enable further testing and battery was found in normal range.Hybrid circuitry was tested, and results indicated normal current drain.A manufacturing anomaly may have occurred, which resulted in the header bonding anomaly and the reported events of inability to interrogate and no pacing.The device is included in the assurity and endurity pacemakers header anomaly advisory issued by abbott on 15 march 2021.

• Brand Name: ASSURITY RF DR
• 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: 15798948
• MDR Text Key: 303659859
• Report Number: 2017865-2022-45445
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507073
• UDI-Public: 05414734507073
• 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: 02/05/2023

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: 06/30/2021
• Device Model Number: PM2240
• Device Catalogue Number: PM2240
• Device Lot Number: A000091010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/06/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 11/09/2022; 01/25/2023
• Supplement Dates FDA Received: 11/30/2022; 02/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2019
• 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
• Treatment: ISOFLEX RIGHT VENTRICULAR LEAD; TENDRIL RIGHT ATRIAL LEAD
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 82 YR
• Patient Sex: Female