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Adverse Event Report

CARDIAC PACEMAKERS VIGOR DR PULSE GENERATOR IMPLANTABLE PULSE GENERATOR   back to search results
Model Number 1230
Event Date 04/03/1997
Event Type  Malfunction   Patient Outcome  Other;
Event Description

Event description cpi received information that during the attempted implant of this implantable pulse generator (ipg), the physician was unable to insert a lead in the ventricular port of the connector block. The physician elected not to implant the ipg.

 
Manufacturer Narrative

Event conclusion cpi analysis found the device passed automated electrical measurements and paced and sensed normally during all tests. Microscopic visual inspection of both lead barrels did not reveal anything that could have contributed to difficult lead insertion. There was no excessive medical adhesive in either lead barrel. All sleeves were found to be round. Leads and gauge pins were able to be fully inserted into each lead barrel without difficulties. Unit meets specifications, therfore cpi could not confirm the allegation.

 
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Brand NameVIGOR DR PULSE GENERATOR
Type of DeviceIMPLANTABLE PULSE GENERATOR
Baseline Brand NameVIGOR
Baseline Generic NameIMPLANTABLE PULSE GENERATOR
Baseline Catalogue NumberNA
Baseline Model Number1230
Other Baseline ID NumberSERIAL
Baseline Device FamilyVIGR
Baseline Device 510(K) Number
Baseline Device PMA NumberP940031
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)24
Date First Marketed05/08/1992
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
richard roy
4100 hamline ave north
st. paul , MN 55112
(612) 582 -5864
Device Event Key106928
MDR Report Key108794
Event Key102302
Report Number2124215-1997-01675
Device Sequence Number1
Product CodeDXY
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 04/07/1997
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 Date10/31/1997
Device MODEL Number1230
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer04/29/1997
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Device Age17 mo
Event Location Hospital
Date Report TO Manufacturer04/07/1997
Date Manufacturer Received04/07/1997
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/31/1995
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 4185/202308 WAS IMPLANTED 03-APR-1997 04/03/1997
2 THE DEVICE 1230/402876 WAS IMPLANTED 03-APR-1997 04/03/1997

Database last updated on February 28, 2009

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