BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2619838 · Received June 18, 2012

    Report

    Report Number
    3004209178-2012-04592
    Event Type
    Malfunction
    Date Received
    June 18, 2012
    Report Date
    May 22, 2012
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 7482A40, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2009; PRODUCT TYPE: EXTENSION, PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009; PRODUCT TYPE: EXTENSION, PRODUCT ID: 3389S-40, LOT#: V230720, IMPLANTED: (B)(6) 2009; PRODUCT TYPE: LEAD, PRODUCT ID: 3389S-40, LOT#: V234704, IMPLANTED: (B)(6) 2009; PRODUCT TYPE: LEAD, PRODUCT ID: 7426, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2009; PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD ISSUES WHERE THE IMPLANTABLE NEUROSTIMULATOR (INS) CUT ON AND OFF. THE REPORTER STATED THIS OCCURRED WHEN THE PATIENT GOES THROUGH METAL DETECTORS AT THE STORE OR AIRPORT. THE REPORTER FURTHER STATED THIS OCCURRED PERIODICALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) TURNED OFF AFTER WALKING THROUGH STORE SECURITY AND AFTER USING A DRILL, WHICH CAUSED HIM TO SWEAT PROFUSELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MANUFACTURER REPORT #3004209178-2012-04591.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1