BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3080264 · Received April 26, 2013

    Report

    Report Number
    3007566237-2013-01442
    Event Type
    Injury
    Date Received
    April 26, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE PATIENT WAS "PRETTY SICK" AND HAD SOME OTHER SURGICAL HEALTH CONSIDERATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DOCTOR WAS CONSIDERING EXPLANTING A NEUROSTIMULATOR DUE TO THE PATIENT'S DISCOMFORT AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE. IT WAS STATED THAT THE INS HAD MIGRATED AND "PERHAPS PROTRUDING OR ERODING THROUGH THE SKIN". NO SPECIFIC DETAILS WERE KNOWN. ABOUT THREE WEEK LATER IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AND THE PATIENT WAS "BACK TO THEIR BASELINE" THE NEXT DAY IT WAS REPORTED THAT THE PATIENT HAD THEIR ENTIRE SYSTEM REMOVE. IT WAS UNCLEAR WHY THE DEVICE WAS IMPLANTED FOR. THE REASON FOR EXPLANT WAS ALSO UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180956 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention