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Adverse Event Report

CARDIAC PACEMAKERS, INC ENDOTAK RELIANCE IMPLANTABLE LEAD   back to search results
Model Number 0158
Device Problem Performance
Event Date 06/17/2004
Event Type  Malfunction   Patient Outcome  Other;
Manufacturer Narrative

Event conclusion the implanting physician is new to this procedure and no lead involvement is suspected. The pneumothorax occurred without threat to the patient and it was allowed to resolve independent of medical intervention. The lead remains implanted. This event will be reopened and updated upon receipt of additional information.

 
Event Description

Event description guidant received information that during the procedure to implant this transvenous defibrillation lead, a pneumothorax occurred.

 
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Brand NameENDOTAK RELIANCE
Type of DeviceIMPLANTABLE LEAD
Baseline Brand NameENDOTAK RELIANCE
Baseline Generic NameIMPLANTABLE LEAD
Baseline Catalogue NumberNA
Baseline Model Number0158
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
CARDIAC PACEMAKERS, INC
guidant puerto rico b.v.
#12, rd. #698
dorado PR 00646 UNK
Manufacturer (Section D)
CARDIAC PACEMAKERS, INC
guidant puerto rico b.v.
#12, rd. #698
dorado PR 00646 UNK
Manufacturer (Section G)
CARDIAC PACEMAKERS, INC.
4100 hamline ave., north
st. paul MN 55112 5798
Device Event Key533531
MDR Report Key544123
Event Key516795
Report Number2124215-2004-08283
Device Sequence Number1
Product CodeLWS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 06/17/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/10/2004
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator UNKNOWN
Device MODEL Number0158
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Report TO Manufacturer06/17/2004
Date Manufacturer Received06/17/2004
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 08/10/2004 Patient Sequence Number: 1
#TreatmentTreatment Date
1 THE DEVICE 4469/417313 WAS IMPLANTED 17-JUN-2004 06/17/2004
2 THE DEVICE A155/107527 WAS IMPLANTED 17-JUN-2004 06/17/2004

Database last updated on January 30, 2009

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