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Adverse Event Report

CARDIAC PACEMAKERS, INC ENDOTAK ENDURANCE EZ IMPLANTABLE LEAD   back to search results
Model Number 0154
Device Problems Normal; Damage, internal/external
Event Date 06/14/2004
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Guidant received information that this implantable device and leads were explanted secondary to a patient infection. Guidant received additional information that during the extraction, this transvenous defibrillation lead separated at the distal coil. The distal portion of the lead was unable to be removed during the initial procedure. The patient was referred to the operating room for a further invasive procedure. There were no adverse patient affects reported.

 
Manufacturer Narrative

The remainder of the lead was removed in the or and the patient also received epicardial leads in that same procedure. He was subsequently re-implanted with a gdt heart failure device. All is well with the patient.

 
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Brand NameENDOTAK ENDURANCE EZ
Type of DeviceIMPLANTABLE LEAD
Baseline Brand NameENDOTAK ENDURANCE EZ
Baseline Generic NameLEAD
Baseline Catalogue NumberNA
Baseline Model Number0154
Baseline Device FamilyENEZ
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 Marketed06/15/1999
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
Manufacturer Contact
richard roy
4100 hamline ave north
st paul , MN 55112
(651) 582 -5864
Device Event Key533547
MDR Report Key544139
Event Key516811
Report Number2124215-2004-08247
Device Sequence Number1
Product CodeLWS
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Lay User/Patient
Remedial Action Other
Type of Report Initial
Report Date 06/14/2004
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 Number0154
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 Manufacturer06/14/2004
Date Manufacturer Received06/14/2004
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 4053/407600 WAS IMPLANTED 13-NOV-2000 11/13/2000
2 THE DEVICE 4512/322687 WAS IMPLANTED 01-DEC-2003 12/01/2003
3 THE DEVICE H175/102637 WAS IMPLANTED 01-DEC-2003 12/01/2003
4 THE DEVICE 4470/371354 WAS IMPLANTED 01-DEC-2003 12/01/2003
5 THE DEVICE 4469/418132 WAS IMPLANTED 13-JUL-2004 07/13/2004
6 THE DEVICE H170/504502 WAS IMPLANTED 13-JUL-2004 07/13/2004
7 THE DEVICE 0180/100259 WAS IMPLANTED 13-JUL-2004 07/13/2004

Database last updated on February 28, 2009

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