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

Model Number 5626

Device Problem No Pacing (3268)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2023

Event Type  Injury  

Manufacturer Narrative

Further information was requested but not received.

Event Description

It was reported that the patient presented for a routine pacemaker replacement procedure.Upon interrogation, the pacemaker exhibited loss of low voltage output in response to electrocautery.The pacemaker was explanted and replaced.The patient was in stable condition.

Manufacturer Narrative

The reported event of no pacing was not confirmed.Final analysis found that the device received from the field in backup operation and battery at having reached end of service level.Visual inspection found electrocautery marks on the can consistent with the pacing anomaly reported by the field during the explant procedure.Electrical analysis performed, after replacing the battery, indicates normal functionality.Further evaluation of the output parameters found normal pacing with parameters within normal range.Longevity assessment was performed, and the device exceeded projected longevity indicating normal battery depletion.

• Brand Name: ZEPHYR XL SR
• 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: 16483485
• MDR Text Key: 310675807
• Report Number: 2017865-2023-11773
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734501712
• UDI-Public: 05414734501712
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2010
• Device Model Number: 5626
• Device Catalogue Number: 5626
• Device Lot Number: 2746729
• 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: 04/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2009
• 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
• Patient Outcome(s): Required Intervention