MAUDE Adverse Event Report: ST. JUDE MEDICAL, CRMD INTEGRITY AFX DR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number 5342

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 07/20/2011

Event Type  Injury  

Event Description

It wa reported that an asymptomatic patient was presented in clinic for the follow up in back vvi operation.Memory corruption was confirmed with a single bit flip.Device was explanted and replaced.

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.Evaluation: final analysis found the device exhibited backup vvi operation due to single bit flipped in the product code.After the product code was downloaded, normal function resumed.

• Brand Name: INTEGRITY AFX DR
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, 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: 4191752
• MDR Text Key: 4985035
• Report Number: 2017865-2014-04754
• Device Sequence Number: 1
• Product Code: LWP
• 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: 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: 11/30/2002
• Device Model Number: 5342
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/05/2011
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/20/2011
• Device Age: 10 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/20/2011
• Initial Date FDA Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2001
• 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: 84 YR