MAUDE Adverse Event Report: ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISIONDURATA STS OPTIM ACTIVE FIXATIONDEFIBRILLATION LEAD

Model Number 7120/65

Device Problem Oversensing

Event Date 01/17/2011

Event Type  Injury   Patient Outcome  Required Intervention

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received analysis found damage on the lead body distal to the trifurcation boot indicating exposure to an external abrasion caused by friction to the icd can or another lead. The metal filars of the damaged sensing coil were flattened due to the abrasion. This damage may cause the reported noise.

Event Description

It was reported that noise was seen on the ventricular channel. The lead was explanted and replaced.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION
• Type of Device: DEFIBRILLATION LEAD
• Manufacturer (Section F): ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION; 15900 valley view court; na; sylmar CA 91342
• Manufacturer (Section D): ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION; 15900 valley view court; na; sylmar CA 91342
• Manufacturer (Section G): ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION; 15900 valley view court; na; sylmar CA 91342
• Manufacturer Contact: noemi schambach ; 15900 valley view court; na; sylmar , CA 91342; (408) 522 -6774
• Device Event Key: 2045107
• MDR Report Key: 2015091
• Event Key: 1912087
• Report Number: 2017865-2011-02113
• Device Sequence Number: 1
• Product Code: NVY
• Report Source: Manufacturer
• Source Type: User facility,Company Representative
• Reporter Occupation: Other Health Care Professional

Remedial Action

• Type of Report: Initial

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 03/10/2011
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device EXPIRATION Date: 08/31/2011
• Device MODEL Number: 7120/65
• Device Catalogue Number: SMTFY999
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 01/25/2011
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/17/2011
• Device Age: 29 mo
• Event Location: Hospital
• Was The Report Sent To Manufacturer?: No
• Date Manufacturer Received: 01/18/2011
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 08/18/2008
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Is the Device an Implant?: No

Is this an Explanted Device?

• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 03/10/2011 Patient Sequence Number: 1

#	Treatment	Treatment Date
NA