BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2860381 · Received December 6, 2012

    Report

    Report Number
    3007566237-2012-02918
    Event Type
    Injury
    Date Received
    December 6, 2012
    Report Date
    August 1, 2013
    Manufacturer
    NEURO - VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 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. PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION.

    Description of Event or Problem · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN INFECTION WHEN THE PATIENT WAS INITIALLY IMPLANTED. HEALTH CARE PROVIDER WAS WONDERING WHETHER THE PATIENT SHOULD BE PRE-MEDICATED WITH ANTIBIOTICS PRIOR TO COLONOSCOPY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3389S-40 V972376

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention