BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 2811269 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16105
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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): THE PARTIAL LEAD IN SEGMENTS WAS RETURNED TO THE MANUFACTURER AND ANALYZED. THE OUTER INSULATION HAD BREACHED DEPRESSION. THE SLEEVE CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED) AND THE INNER TUBING WAS TORN. THE OUTER INSULATION WAS BREACHED CUT. EXPOSED DEFIBRILLATION COIL HAD A WHITE SUBSTANCE. THE OUTER INSULATION HAD A WHITE SUBSTANCE AND COSMETIC DEPRESSION. THE HELIX/LOBE WAS DISTORTED/BENT AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OVERSENSING WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD WAS EXPLANTED AND REPLACED. 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6943

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| D154ATG IMPLANTABLE PACEMAKER/CARDIO/DEFIB