BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2992125 · Received March 7, 2013

    Report

    Report Number
    6000153-2013-00029
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    NEURO - VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Removal / Correction Number
    Z-0187-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE DEVICE ISSUE OCCURRED DURING SURGERY. IMPEDANCE MEASUREMENTS WERE HIGH NOT ONLY WITH CONTACT 11 BUT ALSO WITH CONTACT 8 AT A FOLLOW UP VISIT WITH THE NEUROLOGIST. THE LEFT ELECTRODE WAS OKAY. THE PROGRAMS WERE ADJUSTED ON THE RIGHT SIDE, FROM CONTACT 8 TO CONTACT 9. THE THERAPEUTIC EFFECT WAS SATISFYING. IT WAS NOTED THAT THE PATIENT EXPERIENCED SOME BEHAVIORAL CHANGES BUT IT WAS PROBABLY DUE TO OVERSTIMULATION. THE AMPLITUDE WAS LOWERED AND THE PATIENT WILL BUILD UP MUCH SLOWER. THE PATIENT'S OVERALL CONDITION WAS GOOD AND THERE WAS A GOOD THERAPEUTIC RESPONSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE HEALTH CARE PROVIDER (HCP) TRIED TO REMOVE THE LEAD CAP, IT DID NOT COME OFF AND BY PULLING, ONE CONTACT WAS DAMAGED. THE LEAD WAS STILL IMPLANTED. ONLY CONTACT ELEVEN WAS DAMAGED, SO THIS WAS NOT USED IN PROGRAMMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97149 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3389-28 VA05SLH

    Patients

    Seq Age Sex Outcome Treatment
    1