BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1923217 · Received November 9, 2010

    Report

    Report Number
    3004209178-2010-09146
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 20, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1 WEEK AFTER THE INS WAS REPLACED, 2 ELECTRODES ON THE RIGHT SUBTHALAMIC NUCLEUS LEAD HAD AN IMPEDANCE READING OF >2000 OHMS. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR EXPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0006066V| EXPLANTED:| IMPLANTED:| MODEL 7426, LOT# NFW130309H| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU007960V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# J0309504V| EXPLANTED:| IMPLANTED:| MODEL 7426, LOT# NFW130311H| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7438, LOT# NHL015649P| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR:| IMPLANTABLE NEURO STIMULATOR:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387, LOT# J0118387V