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

Model Number 5826

Device Problems Electromagnetic Interference (1194); Pacing Problem (1439)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2019

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 underwent a procedure unrelated to the device.Prior to the procedure, the device was programmed to pace in the ventricles at 70 beats per minute.During the procedure, the patient's heart rate dropped from 70 beats per minute to 35 beats per minute due to electromagnetic interference caused by the use of electrocautery.The use of electrocautery in close proximity to the device can result in loss of capture due to a reduction in pacing output voltage.The pacing mode and rate setting for the pacemaker was changed.The procedure was completed and the patient was stable following.

• Brand Name: ZEPHYR XL DR
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 9532936
• MDR Text Key: 173251909
• Report Number: 2938836-2019-17398
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734501620
• UDI-Public: 05414734501620
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

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: 05/31/2012
• Device Model Number: 5826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 01/15/2020
• Supplement Dates FDA Received: 01/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2010
• 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 Age: 87 YR