BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 6970379 · Received October 23, 2017

    Report

    Report Number
    3004209178-2017-22374
    Event Type
    Injury
    Date Received
    October 23, 2017
    Report Date
    October 23, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# V012723, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. REFER TO MANUFACTURER REPORT #3004209178-2017-22373 FOR DETAILS PERTAINING TO THE RELATED REPORTABLE EVENT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR DYSTONIA AND OTHER INDICATIONS. IT WAS REPORTED THAT THE INTRACRANIAL LEAD SHOWED SIGNS OF FRACTURE PRIOR TO THE INS REMOVAL. BOTH EXTENSIONS WERE CUT AND THE INS WAS REMOVED. THERE WAS A DISRUPTED CIRCUIT. NO MRI WAS TAKEN BUT AN X-RAY WAS PERFORMED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749289 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention