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Adverse Event Report

CARDIAC PACEMAKERS, INC ENDOTAK RELIANCE IMPLANTABLE LEAD   back to search results
Model Number 0157
Device Problems Performance; Sensing intermittently
Event Date 04/02/2004
Event Type  Malfunction   Patient Outcome  Other;
Event Description

Event description guidant received information that this implantable transvenous defibrillation lead was revised, two days after implant, for an unknown lead malfunction.

 
Manufacturer Narrative

Event conclusion the available information leads us to believe the lead remains implanted. Attempts to obtain additional information were unsuccessful. 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 Number0157
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 Key533407
MDR Report Key543999
Event Key516671
Report Number2124215-2004-07911
Device Sequence Number1
Product CodeDTB
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 04/02/2004
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 Number0157
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 Manufacturer04/02/2004
Date Manufacturer Received04/02/2004
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 6931/201754 WAS IMPLANTED 27-JAN-1998 01/27/1998
2 THE DEVICE 0015/201076 WAS IMPLANTED 27-JAN-1998 01/27/1998
3 THE DEVICE 6986/050914 WAS IMPLANTED 27-JAN-1998 01/27/1998
4 THE DEVICE 6931/201823 WAS IMPLANTED 27-JAN-1998 01/27/1998
5 THE DEVICE 6963 TAF103 WAS USED DURING THE EVENT. 04/02/2004
6 THE DEVICE 6963 TAF103 WAS USED DURING THE EVENT. 04/02/2004
7 THE DEVICE 6966 TAL103 WAS USED DURING THE EVENT. 04/02/2004
8 THE DEVICE H177/100398 WAS IMPLANTED 31-MAR-2004 03/31/2004
9 THE DEVICE 4047/087246 WAS IMPLANTED 31-MAR-2004 03/31/2004

Database last updated on February 28, 2009

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