BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3053142 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04309
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 9, 2013
    Report Date
    March 11, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IN SERVICE, WHILE THE ABANDONED LEAD WAS NOT RETURNED TO BOSTON SCIENTIFIC THEREFORE; THE CLINICAL OBSERVATIONS COULD NOT BE CONFIRMED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT BEFORE POST IMPLANT, THE PATIENT IMPLANTED WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD, EXPERIENCED A SYNCOPAL EPISODE AND SUBSEQUENTLY RE-HOSPITALIZED. UPON DEVICE INTERROGATION, IT WAS NOTED THAT VENTRICULAR FIBRILLATION (VF) WAS DECLARED DUE TO A LOT OF NOISE AND LOW SHOCK IMPEDANCE LESS THAN 20 OHMS. THE DEVICE MISINTERPRETED THE NOISE AS A TRUE VENTRICULAR FIBRILLATION (VF) AND ACCELERATED THE PATIENT'S INTRINSIC RHYTHM CAUSING THE DEVICE TO DELIVER AN INAPPROPRIATE SHOCK TO THE PATIENT; WHICH SUCCESSFULLY CONVERTED THE PATIENT TO A NORMAL SINUS RHYTHM. IN ADDITION, ISOMETRIC LEAD TESTING WAS PERFORMED AND CONFIRMED THE NOISE AND A REVISION PROCEDURE WAS PERFORMED. DURING THE REVISION, THE PHYSICIAN STATED THERE WAS NO VISIBLE DEFECT WITH THE RV LEAD. THE LEAD WAS AGAIN TESTED DURING THE REVISION AND NOISE CONTINUED TO OCCUR. THE PHYSICIAN WAS UNABLE TO REMOVE THE RV LEAD, THEREFORE THE LEAD WAS ABANDONED AND A NEW LEAD WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155073 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R