BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3942172 · Received July 17, 2014

    Report

    Report Number
    6000153-2014-00135
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    NEURO - VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD (LOT# VA0HXZV) FOUND THE DISTAL END WAS BENT OUT OF THE BOX.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE PHYSICIAN NOTICED A "SLIGHT BEND" IN THE DISTAL TIP OF THE LEAD AND DID NOT FEEL COMFORTABLE IMPLANTING IT. ANOTHER LEAD WAS IMPLANTED. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419532 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3387S-40 VA0HXZV

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR