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Adverse Event Report

S CO.,MED REL   back to search results
Model Number 7223CX
Event Date 04/29/2002
Event Type  No Answer Provided  
Event Description

Ni.

 
Manufacturer Narrative

Initial analysis found diode - shorting, low resistance. Further analysis found hybrid damage consistent with a high voltage arc. The cause could not be determined. - evaluation summary - pfr203984h diode - shorting low resistance.

 
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Baseline Brand NameMICRO JEWEL II
Baseline Generic NameIMPLANTABLE PACEMAKER/CARDIO/DEFIB
Baseline Catalogue NumberNA
Baseline Model Number7223CX
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
S CO.,MED REL
*
Manufacturer (Section D)
S CO.,MED REL
*
Device Event Key488682
MDR Report Key499915
Event Key474047
Report Number2647346-2002-00262
Device Sequence Number1
Product CodeLWS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Invalid Data
Remedial Action Other
Type of Report Initial
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/26/2003
Is This An Adverse Event Report? No
Device Operator Invalid Data
Device MODEL Number7223CX
Was Device Available For Evaluation? Device Returned To Manufacturer
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? No
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device? No Answer Provided
Type of Device Usage Invalid Data
Removal/Correction NumberNI

Database last updated on February 28, 2009

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