BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 5166580 · Received October 21, 2015

    Report

    Report Number
    3004209178-2015-21176
    Event Type
    Malfunction
    Date Received
    October 21, 2015
    Report Date
    September 30, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3387-40, LOT # V003964, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3387-40, LOT # V003964, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 748240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 748240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE PATIENT THAT REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) DIDN¿T LAST AS LONG AS THEY WERE TOLD THEY WOULD. THE PATIENT WAS IMPLANTED FOR PARKINSON¿S DUAL. FURTHER FOLLOW-UP IS BEING CONDUCTED TO DETERMINE WHAT SYMPTOMS, IF ANY, DID THE PATIENT EXPERIENCE, WHAT TROUBLESHOOTING OCCURRED, AND IF THE CAUSE OF THE LONGEVITY ISSUE WAS DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696431 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR