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Adverse Event Report

CARDIAC PACEMAKERS VENTRICULAR UNIPOLAR IS-1 LEAD UNIPOLAR LEAD   back to search results
Model Number 4161
Event Date 04/14/1997
Event Type  Malfunction   Patient Outcome  Other;
Event Description

Event description cpi received information that this implantable pulse generator (ipg) and unipolar lead, model 4161, were explanted. The patient was exhibiting numerous episodes of myopotential oversensing, which was noted on a holter monitor. It was indicated that the atrial lead (not a cpi lead) 'does not function'. An invasive procedure was performed to explant the atrial lead and the physician elected to implant a new system.

 
Manufacturer Narrative

Event conclusion the physician elected to upgrade the system to a bipolar system. The lead and ipg were returned to cpi for analysis. The ipg was implanted beyond minimum longevity of 42 months. The ipg passed automated and manual electrical measurements and paced and sensed normally during testing. The ipg meets specifications. Analysis of the returned portion of the lead indicated that the conductor resistance test passed and that the damage to the lead was incurred during the explant procedure.

 
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Brand NameVENTRICULAR UNIPOLAR IS-1 LEAD
Type of DeviceUNIPOLAR LEAD
Baseline Brand NameUNIPOLAR POROUS
Baseline Generic NameLEAD
Baseline Catalogue NumberNA
Baseline Model Number4161
Baseline Device FamilyPTIP
Baseline Device 510(K) NumberK893957
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)48
Date First Marketed08/10/1983
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 Key106949
MDR Report Key108815
Event Key102323
Report Number2124215-1997-01696
Device Sequence Number1
Product CodeDTB
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 04/14/1997
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? No
Device Operator UNKNOWN
Device EXPIRATION Date05/02/1995
Device MODEL Number4161
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer05/16/1997
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Device Age5 yr
Event Location Hospital
Date Report TO Manufacturer04/14/1997
Date Manufacturer Received04/14/1997
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/02/1991
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 0941/712670 WAS IMPLANTED 11-SEP-1991 09/11/1991
2 THE DEVICE 4226/000766 WAS IMPLANTED 07-MAY-1981 05/07/1981
3 THE DEVICE 1230/406241 WAS IMPLANTED 28-APR-1997 04/28/1997
4 THE DEVICE 4269/269040 WAS IMPLANTED 28-APR-1997 04/28/1997
5 THE DEVICE 4285/225381 WAS IMPLANTED 28-APR-1997 04/28/1997

Database last updated on December 31, 2008

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