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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDEDURATA

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ST. JUDE DURATA   Back to Search Results
Model Number 7120
Event Date 04/18/2012
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

Non invasive programmed stimulation of icd, revealed undersensing of ventricular fibrillation after induction. Fluoroscopy of lead revealed externalization of conductors. The externalization was confirmed at lead extraction. The externalization was adjacent to the distal coil of the lead.

 
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Brand NameDURATA
Type of DeviceDURATA
Manufacturer (Section F)
ST. JUDE
Manufacturer (Section D)
ST. JUDE
Device Event Key2592280
MDR Report Key2561677
Event Key2523216
Report NumberMW5025285
Device Sequence Number1
Product CodeLWS
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 04/17/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/02/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number7120
Is The Reporter A Health Professional? Yes
Was The Report Sent To Manufacturer? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?

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