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U.S. Department of Health and Human Services

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

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ST. JUDE MEDICAL RIATA ST OPTIM DEFIBRILLATOR LEAD MODEL 7021 Back to Search Results
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.

 
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Brand NameRIATA ST OPTIM DEFIBRILLATOR LEAD
Type of DeviceMODEL 7021
Manufacturer (Section F)
ST. JUDE MEDICAL
st. paul MN
Manufacturer (Section D)
ST. JUDE MEDICAL
st. paul MN
Device Event Key2654340
MDR Report Key2622612
Event Key2519306
Report NumberMW5025828
Device Sequence Number1
Product CodeLWS
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 Received06/07/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Service Personnel
Device MODEL Number7021
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?

Patient TREATMENT DATA
Date Received: 06/07/2012 Patient Sequence Number: 1
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