BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 2812111 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03837
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    November 13, 2011
    Report Date
    June 26, 2019
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT VENTRICULAR (RV) LEAD HAD VARIABLE IMPEDANCES. THE SUPERIOR VENA CAVA (SVC) COIL WAS MEASURING 68 OHMS AND THEN GREATER THAN 200 OHMS AT THE OFFICE CHECK. THE HIGH VOLTAGE BOTTOM (HVB) COIL WAS MEASURING IN THE 40 OHMS RANGE AND THEN IN THE 60 OHMS RANGE. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO T-WAVE OVERSENSING (TWOS) OF THE RV LEAD. THE RV LEAD WAS EXPLANTED AND REPLACED APPROXIMATELY FOUR MONTHS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6945

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| L| O| R 5076 IMPLANTABLE PACING LEAD| D154VWC IMPLANTABLE PACEMAKER/CARDIO/DEFIB