MAUDE Adverse Event Report: ABBOTT ZEPHYR XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number 5826

Device Problem No Pacing (3268)

Patient Problems Syncope (1610); Syncope/Fainting (4411)

Event Date 09/07/2020

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 the device reached its elective replacement indicator (eri).After the device reached eri, the patient had episodes of syncope due to reduced low voltage output.The device was explanted and replaced to resolve the event.The patient was in stable condition.

Manufacturer Narrative

The analysis of the device did not identify any malfunctions.The device was received in backup vvi mode operation and the battery voltage level at eri, due to normal battery depletion.Device image (stored data) review found the backup mode operation occurred after explant and was consistent with low (cold) temperature exposure.Analysis performed under nominal and various pacing settings, after installing the new battery and reloading the product code, did not identify any anomalies.

• Brand Name: ZEPHYR XL DR
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10804902
• MDR Text Key: 215263468
• Report Number: 2017865-2020-17322
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734501620
• UDI-Public: 05414734501620
• 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,Followup
• Report Date: 01/29/2021

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: 04/30/2015
• Device Model Number: 5826
• Device Catalogue Number: 5826
• Device Lot Number: 4290135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/06/2020
• Supplement Dates Manufacturer Received: 11/10/2020; 01/28/2021
• Supplement Dates FDA Received: 11/17/2020; 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention