BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 5110994 · Received September 29, 2015

    Report

    Report Number
    3004209178-2015-18906
    Event Type
    Injury
    Date Received
    September 29, 2015
    Report Date
    September 3, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID 3387S-40, LOT# V183416, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE PATIENT THAT REPORTED THE COMPLETE DEEP BRAIN STIMULATOR (DBS) SYSTEM WAS REMOVED IN (B)(6) 2009 DUE TO A STAPH INFECTION. FURTHER FOLLOW-UP IS BEING CONDUCTED TO DETERMINE WHAT SYMPTOMS THE PATIENT EXPERIENCED RELATED TO THE INFECTION AND HAD THE INFECTION RESOLVED. THE PATIENT WAS IMPLANTED FOR ESSENTIAL TREMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642814 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention