BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERVENE

    MDR report key: 2412408 · Received January 12, 2012

    Report

    Report Number
    2124215-2011-20361
    Event Type
    Injury
    Date Received
    January 12, 2012
    Date of Event
    December 5, 2011
    Report Date
    September 7, 2012
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION HAVE BEEN MADE. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THERE ARE NO PLANS FOR ADDITIONAL TROUBLESHOOTING OR INTERVENTION. IT WAS ALSO REPORTED THE SHOCKING IMPEDANCE MEASUREMENTS WITH THE PREVIOUS OTHER MANUFACTURER'S DEVICE VARIED IN THE 100 OHMS RANGE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED AT 21 JOULES. THE SHOCK LEAD IMPEDANCES WERE 73 OHMS. IT HAS RECENTLY BEEN IN THE 100-120 OHMS RANGE. THERE ARE NO PLANS FOR ADDITIONAL INTERVENTION AT THIS TIME. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED AN RV LEAD REVISION PROCEDURE WAS PERFORMED. THE RV LEAD WAS SURGICALLY ABANDONED AND A NEW RV LEAD WAS IMPLANTED. THERE WAS NO VISUAL EVIDENCE OF A CONDUCTOR FRACTURE, HOWEVER THE MEASUREMENTS WITH THE NEW LEAD AND THE DEVICE WERE WITHIN NORMAL LIMITS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD WERE EXHIBITING HIGH SHOCKING IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERVENE IMPLANTABLE LEAD NVY GUIDANT ANGLETON/ST. PAUL 497-23

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R 497-23| 101-10| 438-10| E110| MISMATCH| 1861