BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2101749 · Received May 10, 2011

    Report

    Report Number
    3004209178-2011-03365
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    December 1, 2010
    Report Date
    April 11, 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
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SINCE THE IMPLANTABLE NEUROSTIMULATOR WAS REPLACED IN (B)(6) 2010, THE PATIENT EXPERIENCED A SURGING/BUZZING SENSATION GOING UP THE NECK AND TO THE HEAD. IT WAS INDICATED THAT THE SENSATION BEGAN FOLLOWING A FALL, AND THAT IT HAD BEEN GOING ON FOR (B)(6) "DESPITE REPROGRAMMING AND REPLACEMENT OF THE INS." CHECKS OF THE DEVICE SHOWED NOTHING WRONG WITH THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. SEE MFR REPORT #3004209178-2011-03363 REGARDING THE PATIENT'S OTHER DEVICE SYSTEM.

    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 55 YR EXPLANTED:| EXPLANTED:| LOT# NFW164682H| IMPLANTED:| LEAD: MODEL 3389, LOT# J0301118V| IMPLANTED:| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7438, LOT# NHL029612P| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| EXTENSION: MODEL 7482, LOT# NHU038717V| EXTENSION: MODEL 7482, LOT# NHU016012V| IMPLANTED:| LEAD: MODEL 3389, LOT# J0301118V