BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2042495 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01293
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 19, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE RESOLUTION TO THIS MATTER WAS STILL UNDECIDED. INVESTIGATION IS COMPLETED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED AND THE LEAD WAS SURGICALLY ABANDONED DUE TO PATIENT UPGRADE.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD BEEN APPROPRIATELY SHOCKED THIRTEEN TIMES. HOWEVER, THE PACING IMPEDANCE ON THE DEFIBRILLATION LEAD HAD RISEN FROM 600 OHMS TO 2793 OHMS. THIS PATIENT HAS A HISTORY OF LOW POTASSIUM. NO FURTHER PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention T135| 0148