BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4092670 · Received September 16, 2014

    Report

    Report Number
    6000153-2014-00165
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 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

    ANALYSIS OF THE LEAD (LOT # VA0LRYY) FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389S-40, LOT# VA0LLNH, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_STYLET_ACC, PRODUCT TYPE: ACCESSORY. ADDITIONAL ANALYSIS OF THE LEAD, LOT #VA0LRYY, FOUND THE BODY¿S OUTER INSULATION DAMAGED AT THE DEPTH STOP SITE. IMPRESSIONS FROM OVER-TIGHTENING OF THE DEPTH STOP WERE OBSERVED ON THE OUTER INSULATION OF THE LEAD, 8.2 CENTIMETERS FROM THE PROXIMAL END.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LEAD WITH A SHORT CIRCUIT. THE PATIENT ONLY HAD LEADS IMPLANTED AND WAS GOING TO HAVE THE IMPLANTABLE NEUROSTIMULATOR (INS) THE FOLLOWING FRIDAY. THE IMPEDANCES WERE CHECKED DURING THE PROCEDURE AND THEY SAW A SHORT ON 0-3 COMBINATIONS. THEY CHANGED OUT THE LEAD AND THIS RESOLVED THE ISSUE. THERE WERE CONCERNS THAT THE CAUSE OF THE SHORT WAS DUE TO THE LEAD BEING TIGHTENED DOWN TOO HARD ON THE MICRODRIVE. EIGHT DAYS LATER INFORMATION WAS RECEIVED INDICATING THAT IT WAS UNKNOWN WHAT CAUSED THE SHORT. THE ENTIRE LEAD WAS REMOVED AND REPLACED WITH ANOTHER LEAD. IMPEDANCES WERE CHECKED TWICE PRIOR TO REPLACING THE LEAD. THE PATIENT WAS DOING WELL AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571588 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3389S-40 VA0LRYY

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR