BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1993786 · Received January 13, 2011

    Report

    Report Number
    3004209178-2011-00345
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    January 1, 2010
    Report Date
    May 19, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED PROVIDED THAT THE INFO PREVIOUSLY REPORTED IN MANUFACTURER'S REPORT # 3004209178200903397 BELONGS TO THIS FILE: THE INFO REPORTED IN MANUFACTURER'S REPORT # 3004209178200903397 IS AS FOLLOWS: "IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR IS TURNING OFF AND RETURNING TO FACTORY SETTINGS. ADD'L INFO IS BEING REQUESTED." ADD'L INFO REGARDING THE EVENT. IN APRIL IT WAS REPORTED THAT THE PATIENT'S RIGHT DEVICE WAS TURNING OFF. IT HAD TURNED OFF TWO TO THREE TIMES AND RETURNED TO THE FACTORY SETTINGS. THE PT HAD BEEN KEEPING A DIARY FOR THE PAST TWO TO THREE MONTHS AND THEY COULDN'T FIGURE OUT WHAT WAS CAUSING THE DEVICE TO TURN OFF. IT WAS THOUGHT THAT IT WAS POSSIBLY THE DOG'S INVISIBLE FENCING. IN MAY IT WAS REPORTED THAT ELECTRODE IMPEDANCES WERE CHECKED AND ALL VALUES WERE FOUND TO BE WITHIN RANGE. HOWEVER, THE PT WAS HAVING ISSUES WITH THE LEFT DEVICE (SEE MANUFACTURER'S REPORT # 3004209178201004626).

    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 10 YR EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU179665V| EXPLANTED:| LOT# NFW150514H| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387S, LOT# V100240| IMPLANTABLE PULSE GENERATOR: MODEL IPG, LOT UNK| IMPLANTED:| EXPLANTED: