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Adverse Event Report

CARDIAC PACEMAKERS, INC CONTAK RENEWAL 3 IMPLANTABLE CHF GENERATOR   back to search results
Model Number H170
Device Problem Impedance, high
Event Date 04/19/2004
Event Type  Malfunction   Patient Outcome  Other;
Event Description

Event description guidant received information that this cardiac resynchronization therapy defibrillator (crt-d) and associated implantable transvenous defibrillation lead exhibited increased shocking lead impedance measurements, from 111 to 125 ohms, since implant.

 
Manufacturer Narrative

Event conclusion the lead and device were explanted and subsequently replaced with another guidant device and defibrillation lead. The local guidant representative reported that the setscrew was loose. Currently, the lead and device have not been returned for analysis. This event will be reopened should further information become available.

 
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Brand NameCONTAK RENEWAL 3
Type of DeviceIMPLANTABLE CHF GENERATOR
Baseline Brand NameRENEWAL 3
Baseline Generic NameIMPLANTABLE CHF GENERATOR
Baseline Catalogue NumberNA
Baseline Model NumberH170
Baseline Device FamilyRNW3
Baseline Device 510(K) Number
Baseline Device PMA NumberP010012
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)12
Date First Marketed06/13/2003
Manufacturer (Section F)
CARDIAC PACEMAKERS, INC
guidant corporation
4100 hamline avenue north
saint paul MN 55112 *
Manufacturer (Section D)
CARDIAC PACEMAKERS, INC
guidant corporation
4100 hamline avenue north
saint paul MN 55112 *
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 Key533798
MDR Report Key544390
Event Key517062
Report Number2124215-2004-07870
Device Sequence Number1
Product CodeNIK
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Remedial Action Other
Type of Report Initial
Report Date 04/19/2004
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 NumberH170
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 Manufacturer04/19/2004
Date Manufacturer Received04/19/2004
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 0049/201651 WAS IMPLANTED 04-MAY-1999 05/04/1999
2 THE DEVICE 6835/201774 WAS IMPLANTED 04-MAY-1999 05/04/1999
3 THE DEVICE 0125/315360 WAS IMPLANTED 04-MAY-1999 05/04/1999
4 THE DEVICE 1823/100023 WAS IMPLANTED 04-MAY-1999 05/04/1999
5 THE DEVICE 4512/100293 WAS IMPLANTED 04-MAY-1999 05/04/1999
6 THE DEVICE 4046/088596 WAS IMPLANTED 12-APR-2004 04/12/2004
7 THE DEVICE 0180/100151 WAS IMPLANTED 11-MAY-2004 05/11/2004
8 THE DEVICE H177/502174 WAS IMPLANTED 11-MAY-2004 05/11/2004

Database last updated on February 28, 2009

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