MAUDE Adverse Event Report: ST. JUDE MEDICAL RIATA ST OPTIM DEFIBRILLATOR LEADMODEL 7021

Model Number 7021

Event Date 06/05/2012

Event Type  Malfunction  

Event Description

Pt had fluoroscopy of st. Jude riata st defibrillator lead, model 7021, serial (b)(4) on (b)(6) 2012, which showed externalization of the conducting coils. This lead is not part of the recent advisory issued by st. Jude. Reason for use: severe ischemic cardiomyopathy and ventricular tachycardia.

• Brand Name: RIATA ST OPTIM DEFIBRILLATOR LEAD
• Type of Device: MODEL 7021
• Manufacturer (Section F): ST. JUDE MEDICAL ; st. paul MN
• Manufacturer (Section D): ST. JUDE MEDICAL ; st. paul MN
• Device Event Key: 2654340
• MDR Report Key: 2622612
• Event Key: 2519306
• Report Number: MW5025828
• Device Sequence Number: 1
• Product Code: LWS
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/07/2012

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 06/07/2012
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: Service Personnel
• Device MODEL Number: 7021
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was The Report Sent To Manufacturer?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Is the Device an Implant?: Yes

Is this an Explanted Device?