BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1181770 · Received September 30, 2008

    Report

    Report Number
    3004209178-2008-06248
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 5, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ENDCAP APPEARED TO HAVE DAMAGED THE LEAD. IMPEDANCES ON ELECTRODES 0 AND 3 WERE LESS THAN 50 OHMS. THE HCP WAS ABLE TO PROGRAM AROUND THE LOW IMPEDANCE LEADS. THE PATIENT HAD EXCELLENT THERAPY EFFICACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482| EXPLANTED:| PROGRAMMER: MODEL 7438| IMPLANTED:| LEAD: MODEL 3387| EXPLANTED: