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

Model Number 5826

Device Problem No Device Output (1435)

Patient Problem Cardiac Arrest (1762)

Event Date 06/15/2017

Event Type  Injury  

Event Description

It was reported that the patient presented in hospital for routine device change out procedure.In preparation for the replacement and to ensure pacing for the dependent patient, the pulse generator was programmed to asynchronous dual chamber pacing whereupon the physician noted the patient was asystolic.The device was then set to dual atrial and ventricular sensing and pacing which further did not restore normal pacing rhythm until the pacing system analyzer wand was removed whereupon normal pacing rhythm was restored.Subsequently the replacement procedure was successfully performed.The patient was stable and would continue to be monitored.

Manufacturer Narrative

The reported field event of loss of pacing was not confirmed in the laboratory.The device was tested on the bench and no anomalies were found.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6722998
• MDR Text Key: 80345641
• Report Number: 2017865-2017-06206
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2009
• Device Model Number: 5826
• Device Lot Number: 0002145423
• Other Device ID Number: 05414734501620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2007
• 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: 88 YR