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); Failure to Interrogate (1332); No Device Output (1435)

Patient Problem Syncope (1610)

Event Date 03/02/2020

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 hospital due to experiencing syncope.Review of electrograms showed that the pacemaker showed failure to capture and the device could not be interrogated; premature battery depletion was suspected.The device was explanted and replaced; and procedure was completed with the patient in stable condition.

Manufacturer Narrative

Interrogation of the device revealed the device was at eri when received.A longevity calculation was performed and found the battery depletion was normal based on the device usage.The device functionality was bench tested and no anomaly was detected.Based on this information, there was no evidence of device malfunction.

• 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: 9857286
• MDR Text Key: 184229465
• Report Number: 2017865-2020-03180
• 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: 07/20/2020

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: 01/31/2017
• Device Model Number: 5820
• Device Catalogue Number: 5820
• Device Lot Number: S000009252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 06/29/2020
• Supplement Dates FDA Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention