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Adverse Event Report

CARDIAC PACEMAKERS, INC ENDOTAK ENDURANCE RX IMPLANTABLE LEAD   back to search results
Model Number 0145
Device Problem Impedance, high
Event Date 04/28/2004
Event Type  Malfunction   Patient Outcome  Other;
Event Description

Event description guidant received information that this implantable transvenous defibrillation lead was surgically abandoned due to increasing impedance measurements.

 
Manufacturer Narrative

Event conclusion the lead was replaced without incident. This event will be reopened and updated upon receipt of additional information.

 
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Brand NameENDOTAK ENDURANCE RX
Type of DeviceIMPLANTABLE LEAD
Baseline Brand NameENDOTAK ENDURANCE RX
Baseline Generic NameTRANSVENOUS DEFIBRILLATION LEAD
Baseline Catalogue NumberNA
Baseline Model Number0145
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 Key533390
MDR Report Key543982
Event Key516654
Report Number2124215-2004-07920
Device Sequence Number1
Product CodeDTB
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Lay User/Patient
Remedial Action Other
Type of Report Initial
Report Date 04/28/2004
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? No
Is This A Product Problem Report? Yes
Device Operator UNKNOWN
Device MODEL Number0145
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Report TO Manufacturer04/28/2004
Date Manufacturer Received04/28/2004
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 1852/202863 WAS IMPLANTED 24-APR-2003 04/24/2003
2 THE DEVICE 0186/100198 WAS IMPLANTED 28-APR-2004 04/28/2004

Database last updated on February 28, 2009

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