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Adverse Event Report

CARDIAC PACEMAKERS, INC ENDOTAK RELIANCE IMPLANTABLE LEAD   back to search results
Model Number 0158
Device Problems Oversensing; Pace, failure to; Noise
Event Date 06/21/2004
Event Type  Malfunction   Patient Outcome  Other;
Event Description

Event description guidant received information that this implantable transvenous defibrillation lead exhibited noisy signals, oversensing and pacing inhibition. The cause of the noise was undetermined.

 
Manufacturer Narrative

Event conclusion the lead was surgically capped and abandoned. Another guidant implantable transvenous defibrillation lead was subsequently implanted. This event will be reopened should further information become available.

 
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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 Key533482
MDR Report Key544074
Event Key516746
Report Number2124215-2004-08312
Device Sequence Number1
Product CodeLWS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 06/21/2004
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 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 Manufacturer06/21/2004
Date Manufacturer Received06/21/2004
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 H135/776642 WAS IMPLANTED 01-MAR-2004 03/01/2004
2 THE DEVICE 6744/300491 WAS IMPLANTED 02-MAR-2004 03/02/2004
3 THE DEVICE 4047/087188 WAS IMPLANTED 02-MAR-2004 03/02/2004
4 THE DEVICE 0158/135463 WAS IMPLANTED 21-JUN-2004 06/21/2004

Database last updated on January 30, 2009

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