FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

CARDIAC PACEMAKERS, INC. / GUIDANT CORP VENTAK PRIZM 2 DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR   back to search results
Model Number 1861
Device Problems Impedance, high; Noise
Event Date 07/18/2003
Event Type  Malfunction   Patient Outcome  Other;
Event Description

Defibrillator (icd) and transvenous implantable lead exhibited out of range ventricular impedance measurements. Noise was observed on the rate/sense channel. The atrial lead exhibited variable impedance measurements. During the revision procedure, it was discovered that the header had separated from the can. The device was explanted and has been returned for analysis. The leads remain in service.

 
Manufacturer Narrative

Upon receipt in the laboratory, visual inspection confirmed the clinical observation. The header was lifted from the can and five of the six feed thru wires were broken. Review of the device memory revealed a ventricular impedance fault, and two out of range ventricular impedance measurements prior to explant. Although evidence indicates external stress may have been a factor in causing the header to become loose, the root cause of the abnormality was isolated to insufficient bonding between the medical adhesive and the titanium casing. Guidant has implemented manufacturing enhancements to make the bond more robust. No failures of this type have been observed since implementation of the enhancement.

 
Event Description

Event description guidant received information that this implantable cardioverter defibrillator (icd) and transvenous implantable lead exhibited out of range ventricular impedance measurements. Noise was observed on the rate/sense channel. The atrial lead exhibited variable impedance measurements. During the revision procedure, it was discovered that the header had seperated from the can. The device was explanted and has been returned for analysis. The leads remain in service.

 
Manufacturer Narrative

Event conclusion upon receipt in co's laboratory, visual inspection confirmed the clinical observation. The header was lifted from the can and five of the six feed thru wires were broken. Review of the device memory revealed a ventricular impedance fault, and two out of range ventricular impedance measurements prior to explant. Although evidence indicates external stress may have been a factor in causing the header to become loose, the root cause of the abnormality was isolated to insufficient bonding between the medical adhesive and the titanium casing. Guidant has implemented manufacturing enhancements to make the bond more robust. No failures of this type have been observed since implementation of the enhancement.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

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 CORP
4100 hamline ave., north
st. paul MN 55112 5798
Manufacturer (Section D)
CARDIAC PACEMAKERS, INC. / GUIDANT CORP
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 Key514788
MDR Report Key525652
Event Key498936
Report Number2124215-2003-05842
Device Sequence Number1
Product CodeLWS
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Patient
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/01/2004,07/18/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/20/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator UNKNOWN
Device EXPIRATION Date11/13/2001
Device MODEL Number1861
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer08/04/2003
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Device Age32 mo
Date Report TO Manufacturer07/18/2003
Date Manufacturer Received07/18/2003
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/2000
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 02/09/2005 Patient Sequence Number: 1
#TreatmentTreatment Date
1 THE DEVICE WAS EXPLANTED IN 2003. 01/01/2003
2 THE DEVICE A135 WAS IMPLANTED 18-JUL 07/18/2003. 01/01/2003

Database last updated on February 28, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH