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Adverse Event Report

CARDIAC PACEMAKERS, INC CONTAK RENEWAL 3 IMPLANTABLE CHF GENERATOR   back to search results
Model Number H175
Device Problem Impedance, high
Event Date 04/13/2004
Event Type  Malfunction   Patient Outcome  Other;
Event Description

Event description guidant received information that this implantable cardiac resynchonization therapy-defibrillator (crt-d) measured fluctuating ventricular rate/sense impedance, beginning three months post-implant. No noise was present on electrograms and pacing thresholds were steady and within the acceptable range.

 
Manufacturer Narrative

Event conclusion an invasive examination revealed an unseated setscrew. Once seated, all device behavior normalized. This event will be reopened and updated upon receipt of additional information.

 
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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 NumberH175
Other Baseline ID NumberSERIAL
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 ireland
cashel rd.
clonmel, tipperary ireland
UNITED KINGDOM UNK
Manufacturer (Section D)
CARDIAC PACEMAKERS, INC
guidant ireland
cashel rd.
clonmel, tipperary ireland
UNITED KINGDOM 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 Key533830
MDR Report Key544422
Event Key517094
Report Number2124215-2004-07846
Device Sequence Number1
Product CodeNIK
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Lay User/Patient
Remedial Action Other
Type of Report Initial
Report Date 04/13/2004
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 NumberH175
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 Manufacturer04/13/2004
Date Manufacturer Received04/13/2004
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 4469/332140 WAS IMPLANTED 30-JUL-2003 07/30/2003
2 THE DEVICE 4512/320249 WAS IMPLANTED 30-JUL-2003 07/30/2003
3 THE DEVICE 0158/121736 WAS IMPLANTED 30-JUL-2003 07/30/2003

Database last updated on December 31, 2008

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