BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2092982 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-03248
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 11, 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
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND NOTICED THAT TREMORS BEGAN TO RETURN BEGINNING (B)(6) 2011. IT ALSO WAS REPORTED THAT THE STIMULATOR "ACT(ED) LIKE IT (WAS) TRYING TO TURN ALL DAY" AND THAT THE PATIENT EXPERIENCED INTERMITTENT TINGLING IN THE FINGERS AND ON THE SIDE OF THE FACE. IT WAS INDICTED BY THE HEALTH CARE PROFESSIONAL THAT THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION 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 80 YR IMPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU163853V| LEAD: MODEL 3387S, LOT# V067508| IMPLANTED:| PROGRAMMER: MODEL 7738, LOT# NHL022554P