BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2489179 · Received March 13, 2012

    Report

    Report Number
    3004209178-2012-01522
    Event Type
    Injury
    Date Received
    March 13, 2012
    Date of Event
    February 16, 2012
    Report Date
    February 16, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD: MODEL 3387S-40, LOT: V113842, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2012. EXTENSION: MODEL 7482A40, SERIAL: (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: NA. NEUROSTIMULATOR: MODEL 7426, SERIAL: (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: NA. LEAD: MODEL 3387S-40, LOT: V039858, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2012. EXTENSION: MODEL 7482A40, SERIAL: (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEEDED A REVISION SURGERY DUE TO A FRACTURED LEAD. THE IMPEDANCES OF THE FRACTURED LEAD WERE CONSIDERED OPEN AT CONTACTS 2 AND 3. WHEN THE LEAD WAS REMOVED, THE FRACTURED WIRES WERE VISIBLE ON THE PROXIMAL PORTION OF THE LEAD. IT WAS SUSPECTED THE FRACTURE WAS DUE TO THE PATIENT'S SEVERE DYSTONIA. THE LEAD REVISION WAS SUCCESSFUL AND THE PATIENT WAS DOING "GOOD." IT WAS NOTED THAT THE PATIENT HAD BILATERAL LEAD REPLACEMENTS; IT IS UNKNOWN WHICH LEAD WAS FRACTURED. IF ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW UP REPORT WILL BE SENT.

    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 59 YR Required Intervention