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Adverse Event Report

CARDIAC PACEMAKERS ENDOTAK DOWN-SIZED PLUS TRANSVENOUS DEFIBRILLATION LEAD   back to search results
Model Number 0125
Event Date 03/26/1997
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Event description cpi received information that the rate sensing portion of this endotak down-sized plus lead was capped. The patient with an implantable cardioverter defibrillator (icd) and this lead was experiencing oversensing and inappropriate therapy. The physician elected to perform an invasive procedure to replace the rate sensing portion, in order to remove the pin from the device the physician tried to loosen the screws on the header. On one screw he broke off, another screw broke in such a way that is was impossible to remove the broken part of the screw driver from the inside of the screw. A new icd was implanted.

 
Manufacturer Narrative

Event conclusion cpi's analysis found: only the terminal pin section was returned. Outer insulation of the rate sensing terminal pin section is torn apart at the distal end of the terminal pin barrel. Rate sense positive conductor coil filars (4) are fractured at the distal end of the terminal pin barrel. Fractured conductor coils and insulation damage are most likely due to a load being applied to the lead either at implant, or due to the position of the lead in the body, coupled with movement. The icd was also returned and cpi's analysis found: the torque wrench tip was stuck in the set screw. All other set screws passed the gauge pin test. The icd was electrically in specification.

 
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Brand NameENDOTAK DOWN-SIZED PLUS
Type of DeviceTRANSVENOUS DEFIBRILLATION LEAD
Baseline Brand NameENDOTAK DSP
Baseline Generic NameTRANSVENOUS DEFIBRILLATION LEAD
Baseline Catalogue NumberNA
Baseline Model Number0125
Baseline Device FamilyDSP
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 Marketed08/04/1994
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 Key106973
MDR Report Key108839
Event Key102347
Report Number2124215-1997-01720
Device Sequence Number1
Product CodeLWS
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 04/17/1997
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 Date02/03/2000
Device MODEL Number0125
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer05/01/1997
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Device Age13 mo
Event Location Hospital
Date Report TO Manufacturer04/17/1997
Date Manufacturer Received04/17/1997
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/03/1996
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 1640/700014 WAS IMPLANTED 19-MAR-1996 03/19/1996
2 THE DEVICE 1742/301690 WAS IMPLANTED 26-MAR-1997 03/26/1997

Database last updated on February 28, 2009

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