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

Model Number 5626

Device Problems No Device Output (1435); Pacemaker Found in Back-Up Mode (1440)

Patient Problem Cardiac Arrest (1762)

Event Date 08/13/2012

Event Type  Injury  

Event Description

It was reported that during an upgrade the device was hit with electrocautery and reverted to backup mode.The device was explanted.

Manufacturer Narrative

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.Final analysis confirmed that the device was in backup mode but the product code was intact.Electrocautery marks were found on the can.Delivery of electrocautery to the can was responsible for the backup operation.After downloading the device, the pulse generator behaved normally and passed all tests, electrical and mechanical.

• 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, INC. CRMD; 15900 valley view ct.; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view ct.; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 4209463
• MDR Text Key: 5036240
• Report Number: 2017865-2014-04512
• 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: Health Professional,User Facility,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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2010
• Device Model Number: 5626
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/20/2012
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/13/2012
• Device Age: 46 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/13/2012
• Initial Date FDA Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2008
• 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: 73 YR