BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1861114 · Received October 4, 2010

    Report

    Report Number
    3004209178-2010-07568
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A PROBLEM WITH HIS NEUROSTIMULATOR. THE PT STATED THAT HE FELT "A SHOCKING OR JOLTING SENSATION" THE LAST TIME HE SAW HIS HEALTH CARE PROFESSIONAL. THE HCP FOUND THE IMPLANTABLE NEUROSTIMULATOR TURNED OFF AND TURNED THE DEVICE BACK ON, WHICH "SHOCKED" THE PT FOR "A SHORT PERIOD." THE PT ALSO REPORTED THE RETURN OF THE TREMOR IN HIS LEFT HAND. IT WAS DISCOVERED THAT THE PT WAS TURNING OFF HIS NEUROSTIMULATOR WHEN HE THOUGHT HE WAS TURNING OFF HIS PT PROGRAMMER. THE PT ALSO STATED THAT HE WAS NOT ABLE TO ADJUST HIS STIMULATION. IT WAS REPORTED THAT NO TELEMETRY WAS POSSIBLE WITH THE PT'S IMPLANTABLE NEUROSTIMULATOR LOCATED IN HIS COLLARBONE. THE PT STATED THAT THE BATTERY AT HIS COLLARBONE "SEEMS TO MOVE AROUND." ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE. SEE ALSO MFR'S REPORT #3004209178201007570.

    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 LOT # NFW148015H| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482A51, LOT # NHU171572V| LEAD: MODEL 3387, LOT # V099194| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,