BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK DSP

    MDR report key: 4232347 · Received November 6, 2014

    Report

    Report Number
    2124215-2014-19560
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 DURING A ROUTINE DEVICE CHANGE OUT THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS AS WELL AS LOW, OUT OF RANGE PACE IMPEDANCE MEASUREMENTS WITH THE NEW DEVICE AND VIA THE PACING SYSTEM ANALYZER (PSA). THE LEAD ALSO DISPLAYED LOW R-WAVE MEASUREMENTS. THE LEAD WAS CAPPED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714584 ENDOTAK DSP IMPLANTABLE LEAD LWS HISTORICAL CPI ST. PAUL 0094

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR 1745| 1625| 0094| 1857| 6931