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

Model Number 5820

Device Problems Premature End-of-Life Indicator (1480); Device Inoperable (1663)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 09/30/2013

Event Type  Injury  

Event Description

It was reported that the pulse generator exhibited premature battery depletion.The device was explanted and replaced.No patient complications were reported.

Manufacturer Narrative

All information provided by manufacturer and mandatory medwatch form.(b)(4).Evaluation description: analysis confirmed normal battery depletion.

• 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: 3560061
• MDR Text Key: 4212813
• Report Number: 2017865-2014-00446
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/14/2013,10/13/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2009
• Device Model Number: 5820
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2013
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/30/2013
• Device Age: 71 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/14/2013
• Date Manufacturer Received: 10/24/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2007
• 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 Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 75