BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3062758 · Received April 17, 2013

    Report

    Report Number
    6000153-2013-00072
    Event Type
    Injury
    Date Received
    April 17, 2013
    Report Date
    March 21, 2013
    Manufacturer
    NEURO - VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Removal / Correction Number
    Z-0187-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389-28, LOT# 0206740112, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD. (B)(4). POTENTIAL LEAD DAMAGE ASSOCIATED WITH THE DBS LEAD CAP (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO REMOVE THE LEAD CAP. THE SCREWS WERE TOO TIGHT. THIS RESULTED IN DAMAGE OF THE PROXIMAL CONTACTS OF BOTH LEADS. THE LEADS WERE SCRAPPED BY THE HOSPITAL PERSONNEL. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164425 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3389-28 0206740105

    Patients

    Seq Age Sex Outcome Treatment
    1 00031 YR Required Intervention