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U.S. Department of Health and Human Services

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

The battery was replaced at 2155. The next morning, the battery had no charge and the pacemaker stopped functioning at 0730. The night nurse stated that there was no low battery warning indicator when she checked on the patient at midnight and 0400 and at bedside report at 0700. The patient was pacemaker dependent and went into asystole for about 30 seconds until the patient was connected to the backup pacemaker from the crash cart. ====================== health professional's impression======================per biomed dept: testing in biomed showed no problem, but there is a recall for certain medtronic dual chamber pacemakers (recall # 2011-011, and # 2011-050). The described symptom matches the recall alert, but this pacemaker is not on the medtronic affected list. This is a reportable event. A fresh battery should last for 7 to 9 days, and give a low battery warning indicator 12 hours before the device stops working.

 
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Brand NameDUAL-CHAMBER 5388
Type of DevicePACEMAKER, EXTERNAL, TEMPORARY
Manufacturer (Section F)
MEDTRONIC, INC.
8200 coral sea street ne
mdr product vigilance mvn61
mounds view MN 55112
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mdr product vigilance mvn61
mounds view MN 55112
Device Event Key1987043
MDR Report Key1959895
Event Key1945227
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
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Patient TREATMENT DATA
Date Received: 12/17/2010 Patient Sequence Number: 1
#TreatmentTreatment Date
NOT APPLICABLE
NONE EXCEPT LEADS WHICH WERE FOUND TO BE FUNCTIONI
NG.
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