BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2910210 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16954
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    September 9, 2012
    Report Date
    October 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PHYSICIAN

    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

    SUBSEQUENT INFORMATION INDICATED THAT THE PATIENT WAS SEEN FOR A SURGICAL REVISION PROCEDURE WHERE THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE AND RIGHT VENTRICULAR (RV) LEAD DISPLAYED HIGH, OUT OF RANGE PACE IMPEDANCE MEASUREMENTS. THRESHOLDS HAD INCREASED FROM 0.7 VOLTS TO 1.9 VOLTS AND R AMPLITUDE DROPPED FROM 11 MILLIVOLTS TO 7 MILLIVOLTS. THE LOCAL FIELD REPRESENTATIVE SENT A SAVE TO DISC TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR REVIEW. AFTER REVIEWING THE DISC, TS STATED THAT THE IMPEDANCE MEASUREMENT STEADILY INCREASED OVER TIME. THE MEASUREMENT EVENTUALLY BECAME GREATER THAN 2000 OHMS. THE PATIENT UNDERWENT SUCCESSFUL DEFIBRILLATION THRESHOLD TESTING. THE SYSTEM WAS LEFT AS WAS AND WILL CONTINUE TO BE MONITORED. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18355 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| R E102| 0175