BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK C

    MDR report key: 2910886 · Received January 11, 2013

    Report

    Report Number
    2124215-2013-00012
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    October 1, 2012
    Report Date
    February 27, 2013
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED AND WILL NOT BE RETURNED. 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

    THIS LEAD CURRENTLY REMAINS IMPLANTED. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THROUGH OUR POST MARKET QUALITY ASSURANCE LABORATORY ANALYSIS OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), THAT DAMAGE TO THE ICD COULD HAVE BEEN CAUSED BY AN RIGHT VENTRICULAR (RV) LEAD INTEGRITY ISSUE. THE DAMAGE WAS TO THE DEVICE FUSE AND INTERNAL CIRCUITRY MOST LIKELY OCCURRED DURING DELIVERY OF A HIGH ENERGY SHOCK THROUGH A SHORTED LEAD; HOWEVER, THE ASSOCIATED LEADS WERE NOT RETURNED FOR ANALYSIS SO THIS CANNOT BE DEFINITIVELY CONFIRMED. A NEW COMPETITOR DEVICE WAS IMPLANTED, HOWEVER, THE STATUS OF THE LEAD WAS NOT REPORTED BY THE PHYSICIAN OR COMPETITOR FIELD REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16847 ENDOTAK C IMPLANTABLE LEAD NVY HISTORICAL CPI ST. PAUL 0064

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R 4244| 0064| 6162| 1858| MISMATCH| E110| 1826| 6987| 6931