BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3781588 · Received April 30, 2014

    Report

    Report Number
    3004209178-2014-08259
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 4, 2014
    Report Date
    June 6, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# V248436, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3387S-40, LOT# V054604, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 64002, LOT# N333942, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ADAPTER. PRODUCT ID; 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED 5 DAYS PRIOR TO REPORT AND THEY FELT THE STIMULATION WAS TOO STRONG. IT WAS NOTED THERE WAS A COUPLING PROBLEM. IT WAS FURTHER REPORTED THE PATIENT FELT THEIR STIMULATION SETTING WAS TOO HIGH AND THEY WANTED TO DECREASE THE STIMULATION. IT WAS STATED IT WOULD MAKE THEM SICK WHEN THE STIMULATION WAS ON. IT WAS NOTED THE PATIENT HAD BEEN TURNING THE STIMULATION OFF AT NIGHT. IT WAS NOTED THEY FELT NAUSEOUS ¿LIKE TOO MUCH IN THEIR HEAD.¿ IT WAS STATED THE PATIENT WAS ABLE TO DECREASE THE STIMULATION ON THE RIGHT SIDE FROM 5.50 TO 5.20. IT WAS NOTED THE PATIENT FELT BETTER SHORTLY AFTER THE ADJUSTMENT. IT WAS STATED THEY ALSO DECREASED THE STIMULATION FROM 3.30 TO 3.20 ON THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260449 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR