BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2191720 · Received July 22, 2011

    Report

    Report Number
    3004209178-2011-05659
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 19, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY A MFR EMPLOYEE. TRAINING IS IN PLACE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STIMULATION WAS TURNING OFF INTERMITTENTLY ON ONE SIDE DURING THE NIGHT. ADD'L INFO HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MFR REPORT # 3004209178-2011-05658.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| IMPLANTED:| LEAD: MODEL 3389S, LOT # V435220| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT # NHU036267V| EXTENSION: MODEL 7482, LOT # NHU036284V| EXPLANTED:| EXPLANTED:| LOT # NFW153760H| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7438, LOT # NHL009706P| LEAD: MODEL 3387, LOT # J0348833V