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Adverse Event Report

CARDIOTRONICS, INC. DEFIBRILLATOR/PACER PAD   back to search results
Model Number 825
Patient Outcome  Other;
Event Description

A 67-year-old male underwent cardioversion procedure. Anterior and posterior skin areas at pad contact points remained bright red one hour after cardioversion.

 
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Brand NameDEFIBRILLATOR/PACER PAD
Type of DeviceDEFIBRILLATOR/PACER PAD
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
CARDIOTRONICS, INC.
carlsbad CA 92008
Device Event Key19625
MDR Report Key19722
Event Key17928
Report NumberMW1005131
Device Sequence Number1
Product CodeLDD
Report Source Voluntary
Report Date 01/27/1995
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/14/1995
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number825
Was Device Available For Evaluation? No
Is the Device an Implant? No
Is this an Explanted Device?

Database last updated on February 28, 2009

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