BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2182288 · Received July 11, 2011

    Report

    Report Number
    3004209178-2011-05278
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 16, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND A RETURN OF HIS SYMPTOMS. HE MET WITH A MFR'S REP TO HAVE HIS IMPLANTABLE NEUROSTIMULATORS CHECKED. HE STATED THAT THE BATTERY LEVELS "ARE COMPLETELY DOWN" AND THEY HAVE "FAILED." A REPLACEMENT WAS SCHEDULED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE. SEE ALSO MFR REPORT #3004209178-2011-05280.

    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 50 YR LOT #NFW154253H| EXPLANTED:| LEAD: MODEL 3387, LOT #J0343947V| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| LEAD: MODEL 3387, LOT #J0401947V| EXPLANTED:| EXTENSION: MODEL 7482, LOT #NHU023358V| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT #NHU042248V| IMPLANTED:| IMPLANTED:| EXPLANTED: