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Adverse Event Report

CARDIAC PACEMAKERS VENTAK AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR   back to search results
Model Number 1555
Event Date 04/18/1997
Event Type  Malfunction   Patient Outcome  Other;
Event Description

Event description cpi received information that the implantable cardioverter defibrillator (icd) was returned for normal eri. Testing of the icd noted the patient counters and test shock counters were reset to zero.

 
Manufacturer Narrative

Event conclusion cpi's analysis found: the icd underwent a memory reset which set the pateint counters and test shock counters to zero. We were uanble to determine cause for the reset.

 
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Brand NameVENTAK AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Type of DeviceIMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Baseline Brand NameVENTAK AICD
Baseline Generic NameIMPLANTABLE DEFIBRILLATOR
Baseline Catalogue NumberNA
Baseline Model Number1555
Baseline Device FamilyVEN
Baseline Device 510(K) Number
Baseline Device PMA NumberP890061
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)12
Date First Marketed09/20/1988
Date Ceased Marketing03/01/1997
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 Key106981
MDR Report Key108847
Event Key102355
Report Number2124215-1997-01728
Device Sequence Number1
Product CodeLWS
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 04/30/1997
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
Is This A Product Problem Report? Yes
Device Operator UNKNOWN
Device EXPIRATION Date04/19/1994
Device MODEL Number1555
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer04/08/1997
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Device Age3 yr
Event Location Other
Date Report TO Manufacturer04/30/1997
Date Manufacturer Received04/30/1997
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/19/1993
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 0062/002674 WAS IMPLANTED 30-JUN-1993 06/30/1993
2 THE DEVICE 1746/601363 WAS IMPLANTED 24-OCT-1996 10/24/1996

Database last updated on February 28, 2009

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