BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 3860026 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05616
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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: 5076, LEAD, IMPLANTED: (B)(6) 2001. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE DEVICE CHANGEOUT, THE RIGHT VENTRICULAR (RV) LEAD WAS FOUND TO EXHIBIT HIGH SHOCK COIL IMPEDANCES AND IT WAS NOT POSSIBLE TO OBTAIN A SIGNAL FROM THE LEAD VIA THE ANALYZER. IT WAS SUSPECTED THAT THE LEAD HAD FRACTURED WHILE THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE DEVICE. ADDITIONALLY, IT WAS NOT POSSIBLE TO PASS A STYLET THROUGH THE LEAD. THE LEAD WAS CAPPED AND NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340742 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6945-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R D154AWG ICD