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Adverse Event Report

CARDIAC PACEMAKERS, INC VENTAK PRIZM 2 DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR   back to search results
Model Number 1861
Device Problem Battery, low
Event Date 06/10/2004
Event Type  Malfunction   Patient Outcome  Other;
Event Description

Event description guidant received information that this implantable cardioverter defibrillator (icd), implanted for 25. 3 months, reached a battery status of middle of life 2 (mol2) with a monitoring voltage of 2. 54 volts. The patient is pacing 100% in the atrium and 50% in the ventricle. Outputs are programmed to 2. 6 v @ 0. 5 ms in both chambers. The patient has not recieved any shocks. The physician expressed dissatisfaction with regard to device longevity.

 
Manufacturer Narrative

Event conclusion a guidant technical services consultant performed a longevity calculation with output at these setting and with lead impedances of 438 and 398 in a and v respectively. This calculated to a >5 year longevity, so the consultant was not certain why device was at mol 2 already. The consultant discussed a possibly high current drain; however, this could not be determined until device reaches elective replacement indicator (eri), is explanted and returned for analysis. The physician is planning to observe the patient until the device reaches eri. The available information leads us to believe the device remains implanted and in-service. This event will be reopened should further information become available.

 
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Brand NameVENTAK PRIZM 2 DR
Type of DeviceIMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Baseline Brand NameVENTAK PRIZM 2 DR
Baseline Generic NameIMPLANTABLE CARDIOVERTER DEFIBRILLATOR
Baseline Catalogue NumberNA
Baseline Model Number1861
Other Baseline ID NumberSERIAL
Baseline Device FamilyPRZ2
Baseline Device 510(K) Number
Baseline Device PMA NumberP960040
Baseline Shelf Life Information Yes
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)12
Date First Marketed08/04/2000
Manufacturer (Section F)
CARDIAC PACEMAKERS, INC
guidant ireland
cashel rd.
clonmel, tipperary ireland UNK
UNITED KINGDOM UNK
Manufacturer (Section D)
CARDIAC PACEMAKERS, INC
guidant ireland
cashel rd.
clonmel, tipperary ireland UNK
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 Key533587
MDR Report Key544179
Event Key516851
Report Number2124215-2004-08209
Device Sequence Number1
Product CodeLWS
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Lay User/Patient
Remedial Action Other
Type of Report Initial
Report Date 06/10/2004
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 Number1861
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 Manufacturer06/10/2004
Date Manufacturer Received06/10/2004
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 6947/TDG044 WAS IMPLANTED 06-MAY-2002 05/06/2002

Database last updated on February 28, 2009

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