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

Model Number 1458Q/86

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

Patient Problem Muscle Stimulation (1412)

Event Date 10/30/2012

Event Type  malfunction  

Event Description

It was reported that the pt experienced diaphragmatic stimulation.The lead was deactivated.

Manufacturer Narrative

All information provided by the 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.

• Brand Name: QUARTET
• Type of Device: PERMANENT PACEMAKER ELECTRODE, 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 ct.; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 4268474
• MDR Text Key: 5224735
• Report Number: 2017865-2014-02562
• Device Sequence Number: 1
• Product Code: DTS
• 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: 08/31/2015
• Device Model Number: 1458Q/86
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/30/2012
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 11/19/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• 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 Age: 60 YR