BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 6532244 · Received April 29, 2017

    Report

    Report Number
    2124215-2017-07302
    Event Type
    Malfunction
    Date Received
    April 29, 2017
    Date of Event
    April 30, 2013
    Report Date
    February 13, 2017
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073/S043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL MDR# 2124215-2013-08088 FOR A 0180/ 101569 WAS SUBMITTED ON JULY 8, 2013 - THIS REPORT WAS UPDATED TO REFLECT ONLY THE DEVICE E163/103249 ON (B)(6) 2013. DUE TO INTERNAL SYSTEM LIMITATIONS A NEW COMPLAINT WAS CREATED ON THE LEAD TO CAPTURE AND REPORT THIS ADDITIONAL INFORMATION ON THIS LEAD. 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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THIS ICD WAS LATER EXPLANTED TO UPGRADE TO A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313715 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR 0180| E163| MISMATCH| T180