BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3770479 · Received April 24, 2014

    Report

    Report Number
    6000153-2014-00078
    Event Type
    Injury
    Date Received
    April 24, 2014
    Report Date
    April 4, 2014
    Manufacturer
    NEURO - VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3389S-40, LOT# V011687, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING A MRI BECAUSE THE LEAD WAS BROKEN AND THEY WANTED TO PLACE A NEW ONE. THE REPORTER DID NOT KNOW WHEN THE LEAD BREAK OCCURRED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MANUFACTURING REPORT #6000153-2014-00077 AS THE PATIENT ONLY HAD TWO LEADS IMPLANTED AT THE TIME OF THE REPORT AND IT WAS NOT SPECIFIED WHICH BROKE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAUSE OF THE EVENT WAS FRAYING OF THE LEAD. THE DAMAGED LEFT ELECTRODE WAS REMOVED AND A FRESH ELECTRODE REPLACED IT. THE COATING OF THE ELECTRODE WAS DISINTEGRATING AND THE WIRES WERE FRAYING ON THE DISTAL END. HOSPITALIZATION WAS REQUIRED AND THE PATIENT OUTCOME WAS MARKED AS A NON-SERIOUS INJURY OR ILLNESS, HE RECOVERED WITHOUT SEQUELA, AND AS A SERIOUS INJURY OR ILLNESS THAT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249589 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3389S-40 V013037

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R