BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1841836 · Received September 21, 2010

    Report

    Report Number
    3004209178-2010-07144
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 21, 2010
    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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SEE ALSO MFR REPORT #3004209178-2010-07145. IT WAS REPORTED THAT THE PT EXPERIENCED A PROBLEM WITH THE DEVICE STIMULATION. THE PT THOUGHT THAT ONE OF THE IMPLANTED DEVICES WAS TURNED OFF. THE PT REPORTED A RETURN OF (UNSPECIFIED) SYMPTOMS. NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE PROVIDED. ADD'L INFO WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE FILED IF ADD'L 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 39 YR IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT#: NHU007150V| EXPLANTED:| LEAD: MODEL 3387, LOT#: J0306891V| EXPLANTED:| EXTENSION: MODEL 7482, LOT#: NHU007156V| EXPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR:| IMPLANTED:| PROGRAMMER: MODEL 7438, LOT#: UNK| IMPLANTED:| EXPLANTED:| IMPLANTED:| MODEL 7426, LOT#: NFW154021H