BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4815506 · Received June 3, 2015

    Report

    Report Number
    3004209178-2015-10198
    Event Type
    Malfunction
    Date Received
    June 3, 2015
    Report Date
    May 13, 2015
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37642, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3389S-40, LOT# V589333, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 37085-60, SERIAL#(B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# V925809, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A WARM FEELING AT THE POCKET. THE IMPLANTS STUCK OUT OF THE PATIENT¿S CHEST, YOU COULD SEE THEM WHEN THE PATIENT STOOD UP. YOU COULD FEEL THE KNOBS AND SEE THE LITTLE BUMPS ON THEM, IT LOOKED AWFUL. IT HAD BEEN LIKE THAT SINCE THE IMPLANT. THE PATIENT STATED THAT ¿SOMETIMES THEY FELT IT MORE THAN OTHER TIMES AND IT FELT WARM SOMETIMES.¿ NO INTERVENTION OR OUTCOME WAS PROVIDED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REFERENCE MANUFACTURER¿S REPORT NUMBER: 3004209178-2015-10197.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT RECEIVED ASSISTANCE FROM THEIR DOCTOR IN (B)(6) AND THEIR CONCERNS WERE RESOLVED. THEY STILL HAD CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT THEY WERE WORKING WITH THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE AND THEY HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2015 IN THE MORNING. ONE UNIT WAS VERY VISIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358443 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR