BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 4833652 · Received June 10, 2015

    Report

    Report Number
    2182208-2015-02022
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    March 13, 2015
    Report Date
    March 13, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    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. CONCOMITANT MEDICAL PRODUCTS: D274DRG, ICD, IMPLANTED: (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACE/SENSE PORTION OF THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD WAS REPLACED WITH ANOTHER LEAD DUE TO HIGH PACING THRESHOLDS AND NO CAPTURE. THE HIGH VOLTAGE PORTION REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376927 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6945-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| R 6940-52 LEAD