BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3813186 · Received May 15, 2014

    Report

    Report Number
    3007566237-2014-01331
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE EXTENSION; PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE EXTENSION; PRODUCT ID 37601, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN IMPEDANCE MEASUREMENT OF >40,000 OHMS ON THE FIRST PRIMARY CELL IMPLANTABLE NEUROSTIMULATOR (INS) THAT WAS USED. IT WAS STATED THEY WERE UNAWARE OF ANY IMPEDANCE ISSUE PRIOR TO THE CHANGE OUT. IT WAS NOTED THEY COULD SEE BLOOD ON THE FIRST PORT AND THEY SWITCHED THE EXTENSION TO THE SECOND PORT, 8-11 AND THEY CONTINUED TO SEE HIGH IMPEDANCE READINGS. IT WAS STATED BLOOD HAD SQUEEZED INTO THE SECOND PORT. IT WAS NOTED THEY HAD TRIED TO SUCTION OUT THE BLOOD BUT WHEN THEY PRESSED ON THE HEADER BLOCK, BLOOD MOVED TO THE SECOND PORT. IT WAS NOTED THE SECOND INS WAS GOING TO BE EXPIRED ON (B)(6) 2014. IT WAS NOTED THEY SAW HIGH IMPEDANCE AND LOW MA. IT WAS NOTED C0 WAS LOW AND THE REST OF THE PAIRS WERE HIGH. IT WAS STATED THEY HAD ¿WASTED¿ TWO INS¿. IT WAS STATED THEY WERE GOING TO REPLACE THE EXTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291329 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR