BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2092387 · Received May 2, 2011

    Report

    Report Number
    3004209178-2011-03196
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 14, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED A SHOCKING OR JOLTING SENSATION ON THEIR RIGHT SIDE, THOUGH THE IMPLANTABLE NEUROSTIMULATOR (INS) IS ON THE LEFT SIDE. IT WAS STATED THE SENSATION GOES AWAY THEN THE INS IS OFF. THE REPORTER STATED THERE IS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. IMPEDANCE MEASUREMENTS WERE NORMAL. TROUBLESHOOTING WAS SUGGESTED, BUT NO PT OUTCOME WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFORMATION 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 65 YR EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# L89407| EXPLANTED:| PROGRAMMER: MODEL 7438, LOT# NHL031530P| IMPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0088969N