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

Model Number 5826

Device Problems Pacing Problem (1439); Battery Problem (2885)

Patient Problem Arrhythmia (1721)

Event Date 11/09/2021

Event Type  Injury  

Event Description

It was reported that the patient presented for a generator change.Interrogation revealed that the pacemaker exhibited high battery impedance.During the procedure, the pacemaker exhibited a lack of pacing due to electrocautery leading to asystole.The device was removed and replaced.The patient had no adverse consequences.

Manufacturer Narrative

The reported events of pacing problem and battery problem could not be confirmed.As received, the device was at elective replacement indicator (eri).A longevity calculation was performed and found the battery depletion was normal based on device usage.Further analysis did not find any anomalies.

• Brand Name: ZEPHYR XL 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 12901201
• MDR Text Key: 281502674
• Report Number: 2017865-2021-37961
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734501620
• UDI-Public: 05414734501620
• 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
• Type of Report: Initial,Followup
• Report Date: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2012
• Device Model Number: 5826
• Device Catalogue Number: 5826
• Device Lot Number: 3308034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2011
• 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: 2088/TC 52 US TENDRILACTIVE LEAD; 2088TC/46 STERILIZED PRUS F/G
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female