BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 1925057 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-13688
    Event Type
    Injury
    Date Received
    December 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    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.

    Description of Event or Problem · 1

    THE PATIENT REPORTED RECEIVING A THERAPY. UPON FOLLOW-UP, IT WAS DETERMINED THAT THE LEAD EXPERIENCED T-WAVE OVERSENSING, WHICH LED TO THE DELIVERY OF AN INAPPROPRIATE THERAPY. THE LEAD IS STILL IN USE. 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6945 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6940 IMPLANTABLE PACING LEAD