BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5427556 · Received February 10, 2016

    Report

    Report Number
    6000153-2016-00409
    Event Type
    Injury
    Date Received
    February 10, 2016
    Report Date
    January 18, 2016
    Manufacturer
    NEURO - VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT(S): PRODUCT ID: 3389S-40, LOT# V972376, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# V972376, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR PARKINSON'S DUAL. IT WAS REPORTED THEY HAD AN INFECTION WHEN THEY WERE INITIALLY IMPLANTED WITH THE DEEP BRAIN STIMULATOR (DBS). THEY INQUIRED IF THEY SHOULD BE PRE-MEDICATED WITH ANTIBIOTICS PRIOR TO THEIR COLONOSCOPY. ADDITIONAL INFORMATION RECEIVED FROM A HEALTH CARE PROFESSIONAL (HCP) REPORTED THE PATIENT'S DEEP BRAIN STIMULATOR (DBS) LEADS AND EXTENSION WERE REMOVED DUE TO INFECTION IN (B)(6) OF 2012. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS LEFT IMPLANTED FOR POTENTIAL FUTURE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84560 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 37085-60

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention