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

Model Number 5376

Device Problems Difficult to Interrogate (1331); Device Operates Differently Than Expected (2913)

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

Event Date 05/03/2012

Event Type  malfunction  

Event Description

It was reported that the pulse generator exhibited low battery voltage, telemetry anomaly, sporadic telemetry signal due to eri/eol.

Manufacturer Narrative

All info provided by mfr, 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: IDENTITY XL DR
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR, LWP
• 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: 4192187
• MDR Text Key: 16306094
• Report Number: 2017865-2014-04337
• Device Sequence Number: 1
• Product Code: LWP
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2006
• Device Model Number: 5376
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/16/2012
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/03/2012
• Device Age: 91 MO
• Event Location: Hospital
• Date Manufacturer Received: 05/03/2012
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2004
• 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