BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3921578 · Received July 9, 2014

    Report

    Report Number
    6000153-2014-00129
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    NEURO - VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3389S-40, LOT# VA02WWS, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT STIMULATION WAS NOT FELT BY THE PATIENT DURING MACROSTIMULATION OR LEAD INTERROGATION. THE LEAD WAS CHANGED OUT AND THE SECOND LEAD RESULTED IN HIGH IMPEDANCES AS WELL, ALTHOUGH LOWER THAN THE FIRST LEAD. TISSUE IMPEDANCE WAS THOUGHT TO BE THE CAUSE. NO ADDITIONAL TROUBLESHOOTING WAS DONE AND THE PATIENT WAS DOING FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE DATE OF THIS REPORT A LEAD WAS BEING ADDED TO ONE SIDE. THE PATIENT HAD A PRE-EXISTING SYSTEM ON THE OTHER SIDE. IT WAS NOTED THAT THEY HAD NOTICED NO BENEFIT OR SIDE EFFECTS WHILE DOING THE MACRO STIMULATION. THERE WAS CONCERN ABOUT THE LEAD LOCATION. LEAD IMPEDANCE WAS TESTED USING EXTERNAL NEUROSTIMULATOR (ENS) AND TWIST LOCK, ALL PAIRS WITH #0 WERE GREATER THAN 40,000 AND OTHERS WERE IN NORMAL RANGE. THE CABLE WAS CHANGED OUT AND THEY HAD STILL GOTTEN GREATER THAN 40,000 ON PAIRS WITH 0. THE LEAD WAS CHANGED OUT AND THE IMPEDANCES WITH 0-1 HAD BEEN GREATER THAN 40,000 BUT OTHER PAIRS WITH 0 WERE STILL HIGH BUT NOT GREATER THAN 40,000. IT WAS NOTED THAT THE PATTERNING WAS NOT CONSISTENT AMONG THE 0 ELECTRODE PAIRS. THE LEAD WAS PLACED MORE VENTRAL. IT WAS NOTED THAT THEY WERE ABLE TO GET A GOOD END RESULT USING ELECTRODE #1. THEY HAD GOTTEN GOOD RESULTS WITH NO SIDE EFFECTS. THE IMPEDANCES WERE LOWER WITH THE SECOND LEAD THAN THEY WERE WITH THE ORIGINAL LEAD THEY HAD STARTED WITH. IT WAS FURTHER NOTED THAT THEY HAD JUST BEEN ADDING A SECOND SIDE ON THE DATE OF THIS REPORT. ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT. REFERENCE MANUFACTURER¿S REPORT NUMBER: 3007566237-2014-01898.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400413 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3387S-40 VA0HZ1F

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR