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Adverse Event Report

CARDIAC PACEMAKERS ENDOTAK C TRANSVENOUS DEFIBRILLATION LEAD   back to search results
Model Number 0064
Event Date 03/24/1997
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Event description cpi received information that this endotak transvenous defibrillation lead (0064) was removed from service because of an insulation break. The physician elected to remove the patient's implantable cardioverter defibrillator (icd) at the same time, a pectoral system was implanted.

 
Manufacturer Narrative

Event conclusion the lead has not been returned to cpi for analysis. Analysis of the icd shows the device passed all testing.

 
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Brand NameENDOTAK C TRANSVENOUS DEFIBRILLATION LEAD
Type of DeviceTRANSVENOUS DEFIBRILLATION LEAD
Baseline Brand NameENDOTAK C
Baseline Generic NameTRANSVENOUS DEFIBRILLATION LEAD
Baseline Catalogue NumberNA
Baseline Model Number0064
Baseline Device FamilyENDO
Baseline Device 510(K) Number
Baseline Device PMA NumberP910073
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)48
Date First Marketed04/20/1990
Manufacturer (Section F)
CARDIAC PACEMAKERS
guidant corporation
4100 hamline avenue north
saint paul MN 55112 UNK
Manufacturer (Section D)
CARDIAC PACEMAKERS
guidant corporation
4100 hamline avenue north
saint paul MN 55112 UNK
Manufacturer (Section G)
CARDIAC PACEMAKERS, INC.
4100 hamline ave., north
st. paul MN 55112 5798
Manufacturer Contact
jason holeman
4100 hamline ave n
st. paul , MN 55112
(651) 582 -5864
Device Event Key106912
MDR Report Key108778
Event Key102286
Report Number2124215-1997-01659
Device Sequence Number1
Product CodeLWS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 04/07/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/08/1997
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator UNKNOWN
Device EXPIRATION Date07/08/1998
Device MODEL Number0064
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Device Age32 mo
Event Location Hospital
Date Report TO Manufacturer04/07/1997
Date Manufacturer Received04/07/1997
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/08/1994
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/08/1997 Patient Sequence Number: 1
#TreatmentTreatment Date
1 THE DEVICE 1625/300299 WAS IMPLANTED 05-AUG-1994 08/05/1994
2 THE DEVICE 1762/603974 WAS IMPLANTED 24-MAR-1997 03/24/1997
3 THE DEVICE 0125/214654 WAS IMPLANTED 24-MAR-1997 03/24/1997

Database last updated on January 30, 2009

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