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

Model Number 5820

Device Problems Premature Discharge of Battery (1057); Pacemaker Found in Back-Up Mode (1440); Battery Problem (2885); Battery Problem: High Impedance (2947); No Pacing (3268)

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

Event Date 01/06/2021

Event Type  Injury  

Event Description

It was reported that the patient presented in clinic for routine follow up.Upon interrogation, it was revealed that the patient's pacemaker exhibited high battery impedance and the elective replacement indicator (eri) was triggered.It was believed that due to premature depletion, the pacemaker had gone into back-up operation.It was further determined that there was no low voltage output.The device was explanted and replaced.The patient was stable.

Manufacturer Narrative

The reported event of backup operation was confirmed and premature depletion was not confirmed.Device image analysis showed that back-up operation occurred because of low battery voltage due to normal usage.No anomalies were found.

• Brand Name: ZEPHYR DR
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11233014
• MDR Text Key: 228833299
• Report Number: 2017865-2021-06200
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734501613
• UDI-Public: 05414734501613
• Combination Product (y/n): N
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Model Number: 5820
• Device Catalogue Number: 5820
• Device Lot Number: 4683921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention