BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 2812921 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15970
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. EVALUATION SUMMARY: (B)(4): NO ANOMALIES FOUND, HOWEVER THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM; FULL LEAD RETURNED AND ANALYZED. (B)(4): NO ANOMALIES FOUND, HOWEVER THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM; FULL LEAD RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT T-WAVE OVERSENSING WAS NOTED. DURING THE ATTEMPTED REPLACEMENT OF THE RV (RIGHT VENTRICULAR) LEAD, THE TWO ATTEMPTED LEADS COULD NOT RESCUE THE PATIENT DURING DFT (DEFIBRILLATION THRESHOLD) TESTING. THE ORIGINAL RV LEAD WAS RETESTED AND HAD SUCCESSFUL DFTS, AND WAS LEFT 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
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| O| R 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB