BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 3861985 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07100
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    April 9, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    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. THE RIGHT VENTRICULAR (RV) LEAD WAS PREVIOUSLY REPORTED ON (B)(6) 2013 VIA ALTERNATIVE SUMMARY REPORTING (B)(4) FOR FRACTURE AND OVERSENSING. CONCOMITANT MEDICAL PRODUCTS: A 5076-45 IMPLANTABLE PACING LEAD, (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS ALLEGED BY A LAWYER THAT THE PATIENT RECEIVED MULTIPLE INAPPROPRIATE SHOCKS CAUSING PAIN. FOLLOWING THE RIGHT VENTRICULAR (RV) LEAD REPLACEMENT PROCEDURE, THE PATIENT EXPERIENCED A CONTUSED AREA AND CELLULITIS INFECTION IN THE UPPER LEFT EXTREMITY WITH PAIN, SWELLING, REDNESS, AND STIFFNESS. THE PATIENT WAS HOSPITALIZED AND TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337510 SPRINT FIDELIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694958

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| L| R D154ATG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR