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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. DUAL-CHAMBER 5388 PACEMAKER, EXTERNAL, TEMPORARY

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MEDTRONIC, INC. DUAL-CHAMBER 5388 PACEMAKER, EXTERNAL, TEMPORARY Back to Search Results
Model Number 5388
Event Date 12/09/2010
Event Type  Malfunction  
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Brand NameDUAL-CHAMBER 5388
Type of DevicePACEMAKER, EXTERNAL, TEMPORARY
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mdr product vigilance mvn61
mounds view MN 55112
MDR Report Key1959895
Report Number1959895
Device Sequence Number1
Product CodeDTE
Report Source User Facility
Type of Report Initial
Report Date 12/17/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/17/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Invalid Data
Device MODEL Number5388
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/17/2010
Device Age11 yr
Event Location Hospital

Patient TREATMENT DATA
Date Received: 12/17/2010 Patient Sequence Number: 1
Treatment
NONE EXCEPT LEADS WHICH WERE FOUND TO BE FUNCTIONI
NG.
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