BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3210341 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08252
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 1, 2012
    Report Date
    April 19, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD HAD PACING IMPEDANCES THAT WERE VARIABLE AND SOME WERE > 2000 OHMS AND NOISE WITH OVERSENSING WAS NOTED ON THE LEAD. THE LEAD'S THRESHOLD WAS 1.5 VOLTS. NO INAPPROPRIATE THERAPY WAS DELIVERED AND THERE WERE NO PAUSES IN PACING AS THE PATIENT IS NOT PACEMAKER DEPENDENT. ATTEMPTS TO REPRODUCE THE OBSERVATIONS WITH ISOMETRICS WERE UNSUCCESSFUL, UNTIL THE PATIENT LEANED FORWARD WITH HIS ARMS ON HIS KNEE. NOISE WAS THEN OBSERVED AND OUT OF RANGE IMPEDANCE MEASUREMENTS WERE OBTAINED. THE PHYSICIAN SUSPECTED A FRACTURE OF THE LEAD. SURGICAL INTERVENTION WAS PERFORMED AND THE LEAD WAS INSPECTED. THERE WERE NO VISIBLE PROBLEMS WITH THE LEAD IDENTIFIED, BUT THE PHYSICIAN OPTED TO SURGICALLY ABANDON THE LEAD. A NEW RV LEAD WAS SUCCESSFULLY PLACED AND THE GENERATOR REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED, AND IT WAS NOTED THE PATIENT DID FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310472 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0138

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R A135| 4473| 0138| E110