BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5072084 · Received September 11, 2015

    Report

    Report Number
    3004209178-2015-17856
    Event Type
    Injury
    Date Received
    September 11, 2015
    Report Date
    August 18, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3389S-40, LOT# V991333, IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2015 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3389S-40, LOT# V884064, IMPLANTED: 2013 (B)(6), EXPLANTED: 2015 (B)(6); PRODUCT TYPE LEAD, (B)(4),

    Description of Event or Problem · 1

    A CONSUMER WHOSE INDICATION FOR USE WAS PARKINSON'S DUAL AND MOVEMENT DISORDERS REPORTED THAT THERE WAS A CONFIRMED INFECTION AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE IN 2014, 1.5 YEARS AFTER INITIAL IMPLANT. THE INFECTION HAD STARTED AT THE INCISION SITE. THE BATTERY HAD TO BE REMOVED BECAUSE OF THE INFECTION. THE WHOLE SYSTEM HAD BEEN EXPLANTED AND THE PATIENT HAD JUST RECENTLY BEEN RE-IMPLANTED WITH A WHOLE NEW SYSTEM. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN INFORMATION ABOUT THE CAUSE. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604039 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention