BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 3092566 · Received May 3, 2013

    Report

    Report Number
    6000032-2013-00113
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 21, 2013
    Report Date
    April 23, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 7438, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3387-40, LOT# J0124807V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE PATIENT WAS AT (B)(6), THE PT EXPERIENCED TINGLING ON HER TONGUE AND SHOCKS DOWN HER ARM. THE PATIENT WAS STANDING BY A WALL, NEAR (B)(6), WHEN SHE SAT DOWN ON THE FLOOR. THE PATIENT WAS BROUGHT INTO A SEPARATE ROOM AND THE SHAKING INITIALLY STOPPED, BUT RETURNED LESS THAN A MINUTE LATER. THE DEVICE WAS REPORTED TO HAVE BEEN TURNED OFF IN 2004. IT WAS SPECULATED THAT THE PATIENT WAS IN AN ELECTROMAGNETIC ENVIRONMENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT RECEIVED ASSISTANCE AND HAD NO FURTHER CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194426 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT SOFAMOR DANEK PUERTO RICO MFG 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR