BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2520819 · Received April 6, 2012

    Report

    Report Number
    2124215-2012-04839
    Event Type
    Injury
    Date Received
    April 6, 2012
    Date of Event
    February 1, 2012
    Report Date
    February 1, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS LEAD WAS THOROUGHLY INSPECTED AND ANALYZED. MICROSCOPIC VISUAL INSPECTION NOTED SEVERAL SURFACE INSULATION ABRASIONS BETWEEN THE TERMINAL PIN AND THE SUTURE SLEEVE TIE DOWN AREA, SOME OF WHICH WERE OVERLAPPING. ADDITIONALLY, TRILUMEN INSULATION WEBBING DAMAGE WAS NOTED BETWEEN THE RS- AND DISTAL HV LUMENS BETWEEN 142-154 AND 168-172MM FROM THE TERMINAL PIN. THE LOCATION AND TYPE OF DAMAGE IS INDICATIVE OF LEAD-ON-LEAD OR LEAD-ON-CAN CONTACT COUPLED WITH PRESSURE AND MOVEMENT. THIS DAMAGE MAY HAVE CONTRIBUTED TO THE OBSERVED NOISE, OVERSENSING, AND INAPPROPRIATE SHOCKS. THE LEAD WAS SUBJECTED TO RESISTANCE TESTING AND WAS CONFIRMED TO BE ELECTRICALLY CONTINUOUS. ANALYSIS DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED OUT-OF-RANGE PACE IMPEDANCE MEASUREMENTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED HIGH OUT OF RANGE (OOR) PACING IMPEDANCE MEASUREMENTS, AND NOISY SIGNALS WHICH RESULTED IN THE DELIVERY OF INAPPROPRIATE SHOCKS. THE DECISION WAS MADE TO PERFORM A LEAD REVISION WITHIN THE NEAR FUTURE. IN THE MEAN TIME THE DEVICE WAS PROGRAMMED TO MONITOR ONLY (MO) UNTIL A REPLACEMENT PROCEDURE TAKES PLACE. SUBSEQUENTLY, ADDITIONAL INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED. THIS RV LEAD WAS EXPLANTED AND REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R