MAUDE Adverse Event Report: ST. JUDE MEDICAL, CRMD AFFINITY DR; IMPLANTABLE PACEMAKER PULSER GENERATOR, LWP

Model Number 5330

Device Problems Pacemaker Found in Back-Up Mode (1440); Loss of Data (2903)

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

Event Date 09/21/2012

Event Type  Injury  

Event Description

It was reported that the pulse generator exhibited backup vvi operation during surgery.The device was explanted and replaced.

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.Analysis found the device exhibited backup vvi operation was confirmed.The root cause could not be determined due to corruption of the product code.

• Brand Name: AFFINITY DR
• Type of Device: IMPLANTABLE PACEMAKER PULSER GENERATOR, LWP
• Manufacturer (Section D): ST. JUDE MEDICAL, 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: 4053804
• MDR Text Key: 4903485
• Report Number: 2017865-2014-09182
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• 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: 10/31/2005
• Device Model Number: 5330
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/03/2012
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/21/2012
• Device Age: 101 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/21/2012
• Initial Date FDA Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2004
• 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