MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. CRMD OPTISENSE; PERMANENT PACEMAKER ELECTRDOE, DTS

Model Number 1999/52

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 12/06/2012

Event Type  Death  

Event Description

It was reported that the pt deceased.

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.A partial lead was returned for analysis.The portion of the lead that was returned as normal.

• Brand Name: OPTISENSE
• Type of Device: PERMANENT PACEMAKER ELECTRDOE, DTS
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 15900 valley view ct.; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view court; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 4105533
• MDR Text Key: 20293604
• Report Number: 2017865-2014-07087
• Device Sequence Number: 1
• Product Code: DTS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Model Number: 1999/52
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/06/2012
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/06/2012
• Device Age: 7 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/06/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 61 YR