MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD ZEPHYR XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number 5826

Device Problem No Device Output (1435)

Patient Problem Ventricular Fibrillation (2130)

Event Date 10/02/2013

Event Type  Injury  

Event Description

It was reported that during a routine device change out, the pulse generator stopped pacing after being exposed to electrocautery.The patient went into ventricular fibrillation.The device was explanted and replaced.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.

• Brand Name: ZEPHYR XL DR
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view court; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 3548422
• MDR Text Key: 4096264
• Report Number: 2017865-2014-00097
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2010
• Device Model Number: 5826
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/02/2013
• Device Age: 53 MO
• Event Location: Hospital
• Date Manufacturer Received: 10/30/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2009
• 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 Outcome(s): Required Intervention
• Patient Age: 83 YR