BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2030880 · Received March 4, 2011

    Report

    Report Number
    3004209178-2011-01659
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 17, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S DEVICE WAS IN A POWER ON RESET CONDITION (POR). IT WAS REPORTED THE PATIENT EXPERIENCED A RETURN OF SYMPTOMS FOR THE WEEK PRIOR TO REPORT. THE POR CONDITION WAS EVENTUALLY CLEARED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE MFR REPORT #3004209178201101661.

    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 63 YR IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7438, LOT# NHL025827P| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37601| EXTENSION: MODEL 37085, LOT# NKN009570V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3389S-40, LOT# V492274| IMPLANTED:| LEAD: MODEL 3389S-40, LOT# V492274| EXPLANTED:| EXPLANTED:| EXPLANTED:| LOT# NKM704600H| EXPLANTED:| LEAD: MODEL 3387S, LOT# V129147| EXTENSION: MODEL 37085, LOT# NKN009583V| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37642, LOT# NJZ106651N| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482A, LOT# NHU179607V