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

Model Number 5826

Device Problem Pacing Problem (1439)

Patient Problems No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that the patient presented for generator change due to eri.The patient's device was interrogated prior to the procedure and the patient was 100% pacemaker dependent with no escape rhythm.When the physician proceeded to cut skin with electrocautery, the device exhibited common-mode inhibition behavior and the patient's rhythm became asystole for approximately 3 minutes until the device started to recover and resumed pacing again.The physician acknowledged that the device did go into common-mode inhibition behavior and they should have had an extra torque wrench and pacing cables connected to the analyzer ready to pace to anticipate for the asystole.The device was replaced.The patient was stable prior to the surgery, nauseous and threw up immediately post-surgery, and stable once transferred to the post-op recovery unit.

Manufacturer Narrative

The reported of pacing problem was not confirmed.Visual examination noted burn marks on device can from exposure to electrosurgical cautery.User¿s manual indicated that electrosurgical cautery can inhibit the pulse generator operation.As received the device operating at normal mode.The results of electrical, stress/environmental tests performed indicate the pacer is exhibiting normal device characteristics.Longevity assessment was performed based on field settings and device was in the normal range of operation with appropriate remaining longevity.Device image was successfully saved.

• 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
• MDR Report Key: 11140405
• MDR Text Key: 225801684
• Report Number: 2017865-2021-00935
• 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
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2011
• Device Model Number: 5826
• Device Catalogue Number: 5826
• Device Lot Number: 2926387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 02/22/2021
• Supplement Dates FDA Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1