BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2607629 · Received June 11, 2012

    Report

    Report Number
    6000153-2012-00134
    Event Type
    Malfunction
    Date Received
    June 11, 2012
    Date of Event
    May 16, 2012
    Report Date
    May 16, 2012
    Manufacturer
    NEURO - VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD, LOT #V902312, FOUND THE LEAD WAS BENT AT THE DISTAL END NEW OUT OF THE BOX.

    Additional Manufacturer Narrative · 1

    PRODUCT ID M924256A003, LOT# 082223811A, SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYP ACCESSORY PRODUCT ID M924256A003, LOT# 082225511A SERIAL#, IMPLANTED: EXPLANTED: PRODUCT TYP ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, WHEN THE HEALTH CARE PROVIDER WAS GOING TO IMPLANT THE DBS LEADS, HE NOTICED THE LEAD TIP WAS BENT. ANOTHER LEAD WAS USED, AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3389S-40 V902312

    Patients

    Seq Age Sex Outcome Treatment
    1