BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2713356 · Received August 24, 2012

    Report

    Report Number
    3004209178-2012-07312
    Event Type
    Injury
    Date Received
    August 24, 2012
    Report Date
    July 26, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3387S-40, LOT # V192123, IMPLANTED: 2009 (B)(6), EXPLANTED: NA, EXTENSION MODEL 7482A51, SERIAL # (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: NA, CONCOMITANT DEVICE SYSTEM: NEUROSTIMULATOR, MODEL 7426, SERIAL # (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: 2012 (B)(6), LEAD MODEL 3387S-40, LOT # V192123, IMPLANTED: 2009 (B)(6), EXPLANTED: NA, EXTENSION MODEL 7482A51, SERIAL # (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: NA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) ON THE RIGHT SIDE REPLACED BECAUSE IT WAS TURNING ON AND OFF OR JUST SHUTTING OFF AND NOT TURNING BACK ON AGAIN. IT WAS NOTED THAT PRIOR TO THE REPLACEMENT SURGERY, THE PATIENT WAS ABLE TO WALK WITHOUT CRUTCHES AND ONLY USED A CANE FOR ASSISTANCE IF NEEDED. SEE ALSO MANUFACTURER'S REPORT # 3004209178-2012-07310 SEE MANUFACTURER'S REPORT #S 3004209178-2012-07307 AND 3004209178-2012-07308 FOR THE PATIENT'S REPLACEMENT DEVICES AND SUBSEQUENT ISSUES.

    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 Required Intervention