BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 3992483 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09841
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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: D154AWG ICD, IMPLANTED: (B)(6) 2007. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE CHANGEOUT IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD AN INSULATION BREACH. A PACE/SENSE LEAD WAS ADDED AND THE HIGH VOLTAGE PORTION OF THE LEAD 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
    468186 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6945

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Hospitalization| R 5076-52 LEAD