BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEET TIP

    MDR report key: 1863594 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15527
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    July 30, 2010
    Report Date
    July 30, 2010
    Manufacturer
    HISTORICAL PUERTO RICO
    Product Code
    NVN
    PMA / PMN Number
    K893957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL SERVICES (TS) REVIEWED THE ELECTROGRAM STRIPS AND CONFIRMED THE ASYSTOLE OF 2 BEATS. TS SUGGESTED A FULL LEAD DIAGNOSTICS, CHEST X-RAY OF THE RV LEAD AND POCKET MANIPULATION WITH SETTING THE SENSITIVITY BACK TO 2.5MV TO TRY AND REPRODUCE THE ISSUE. AS OF THIS REPORT, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WOULD BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT TELEMETRY STRIPS WERE SHOWING INHIBITION OF PACING WITH TWO BEATS OF ASYSTOLE. THE PHYSICIAN WAS CONCERNED WITH A SET SCREW ISSUE AS RIGHT VENTRICULAR (RV) THRESHOLD AND IMPEDANCE MEASUREMENTS WERE STABLE, HOWEVER IT WAS NOTED THAT THE RV LEAD SLACK WAS PULLED TIGHT. RV SENSITIVITY SETTINGS WERE SET AT NOMINALS OF 2.5MV, THEREFORE REPROGRAMMED TO 10MV TO UNDERSENSE. THE PATIENT IS PACEMAKER DEPENDENT, HOWEVER NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWEET TIP IMPLANTABLE LEAD NVN HISTORICAL PUERTO RICO 4269

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR S603| 5076| 0950| 4269| 4285| 1286