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Adverse Event Report

CARDIAC PACEMAKERS, INC. GUIDANT CORP.   back to search results
Patient Outcome  Other;
Event Description

Pt enrolled in madit ii study. One day after implant of aicd, when pt was riding home from hosp. Pt had near syncopal episode. Pt went to local md who then called 911. Bp found to be 80 systolic. Pt taken to er and had ekg, cxr, blood work. Pt told they had gotten dehydrated. Pt implanted with aicd. Pt discharged to home, condition stable.

 
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Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
CARDIAC PACEMAKERS, INC. GUIDANT CORP.
4100 hamline ave north
st. paul MN 55112 5798
Device Event Key264801
MDR Report Key273549
Event Key256468
Report NumberMW1018656
Device Sequence Number1
Product CodeLWS
Report Source Voluntary
Report Date 04/04/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/07/2000
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Invalid Data
Was Device Available For Evaluation? No
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on January 30, 2009

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