MAUDE Adverse Event Report: ST. JUDE MEDICAL INC., CRMD FORTIFY VR, DF-4 CONNECTOR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, LWS

Model Number CD1231-40Q

Device Problems Difficult to Interrogate (1331); Inappropriate or Unexpected Reset (2959)

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

Event Date 01/05/2012

Event Type  malfunction  

Event Description

It was reported that prior to implant the device was in back-up operation and the telemetry was intermittent.This device was exposed to cold.It was not implanted.

Manufacturer Narrative

All info 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 confirmed the field experience of backup vvi operation due to power on reset.Analysis of the device indicated that the device was programmed out of shipped settings.It is believed that the por was caused by the device being exposed to low temperatures after being programmed out of nominal settings.

• Brand Name: FORTIFY VR, DF-4 CONNECTOR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, LWS
• 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: 4063883
• MDR Text Key: 4895293
• Report Number: 2938836-2014-06436
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• 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: 01/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2012
• Device Model Number: CD1231-40Q
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/25/2012
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/05/2012
• Device Age: 7 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/06/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2011
• 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