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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL ST. JUDE MEDICAL ICD 'CURRENT RF-DR' IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR OR ICD

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ST. JUDE MEDICAL ST. JUDE MEDICAL ICD 'CURRENT RF-DR' IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR OR ICD Back to Search Results
Model Number ICD 2207-36
Event Date 10/25/2009
Event Type  Death  
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Brand NameST. JUDE MEDICAL ICD 'CURRENT RF-DR'
Type of DeviceIMPLANTABLE CARDIOVERTER-DEFIBRILLATOR OR ICD
Manufacturer (Section D)
ST. JUDE MEDICAL
one lillehei plaza
st. paul MN 55117
MDR Report Key1702683
Report NumberMW5016115
Device Sequence Number1
Product CodeLWS
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 05/18/2010
3 DeviceS WERE Involved in the Event:1 2 3 
1 Patient Was Involved in the Event
Date FDA Received05/18/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Lay User/Patient
Device MODEL NumberICD 2207-36
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 05/18/2010 Patient Sequence Number: 1
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