BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2993149 · Received March 7, 2013

    Report

    Report Number
    3004209178-2013-03450
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 14, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 748251 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 748251 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 7438 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3389S-40 LOT# V034805, IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3389S-40 LOT# V034805, IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A "LOSS OF THERAPEUTIC EFFECT." IT WAS STATED THAT THE "PATIENT STARTED SHAKING" THE DAY OF REPORT. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS FOUND TO BE TURNED OFF. UPON TURNING THE INS ON, IT WAS STATED THAT THE PATIENT'S "TREMORS STARTED GOING AWAY." IT WAS ALSO REPORTED THAT THE "ISSUE WAS RESOLVED." A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96806 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1