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

Model Number 5626

Device Problems Electromagnetic Interference (1194); Pacemaker Found in Back-Up Mode (1440)

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

Event Date 06/14/2011

Event Type  malfunction  

Event Description

It ws reported that the pulse generator exhibited backup vvi operation and was exposed to cautery.The device was explanted electively due to approaching eri.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.This historical complaint is being filed as part of a retrospective review of complaint files in response to a recent fda inspection.There is no change to the actual performance of the product and this report only represents an enhancement to the reporting criteria going forward.

• Brand Name: ZEPHYR XL SR
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. CRMD.; 15900 valley view ct.; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, CRMD; 15900 valley view ct.; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view ct.; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 4084418
• MDR Text Key: 4740194
• Report Number: 2017865-2014-01529
• Device Sequence Number: 1
• Product Code: DXY
• 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
• Reporter Occupation: Other
• Type of Report: Initial

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: 03/31/2012
• Device Model Number: 5626
• Device Catalogue Number: SMFTY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/14/2011
• Device Age: 9 MO
• Event Location: Other
• Initial Date Manufacturer Received: 06/14/2011
• Initial Date FDA Received: 01/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2010
• 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