BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3879912 · Received June 18, 2014

    Report

    Report Number
    3004209178-2014-11730
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 64002, LOT# N434140, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: ADAPTER. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3387S-40, LOT# V163388, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS DOING WELL WITH ESSENTIAL TREMOR SYMPTOMS AS A RESULT OF THE DEEP BRAIN STIMULATOR (DBS) BUT NOTED WHENEVER THE PATIENT WOULD TOUCH THE RIGHT CORNER OF THE BATTERY THEY WOULD GET A SHARP SHOOTING SENSATION DOWN THEIR RIGHT ARM. IT WAS STATED IT COULD HAPPEN WHEN THE PATIENT WOULD ROLL IN THEIR BED. IT WAS NOTED THE PATIENT HAD THIN SKIN AND THEY COULD SEE THE EXTENSION WIRE GOING INTO THE PORT. IT WAS STATED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS PALPATED AND NOTHING HAPPENED UNTIL THEY PRESSED WHERE THE WIRE CONNECTED TO THE INS. IT WAS NOTED THEY RAN IMPEDANCES AND THEY WERE WITHIN RANGE 800-1200 OHMS FOR ALL CONTACTS ON BOTH SIDES. IT WAS STATED THE DOCTOR HAD CONSIDERED REVISION TO MOVE THE ADAPTOR TO THE BACK PORT AND USE SILICONE NEAR THE HEADER BLOCK. IT WAS STATED IMAGINE HAD NOT BEEN PERFORMED YET AT THE TIME OF REPORT. IT WAS NOTED PERHAPS FLUID MOVED AROUND WHEN THE INS WAS TOUCHED LIKE THAT. IT WAS FURTHER REPORTED THERE WAS A SUSPECTED FLUID LEAK AT THE ADAPTOR/INS CONNECTION WHEN PRESSURE WAS APPLIED AT THAT SITE. IT WAS NOTED THE ISSUE WAS NOT RESOLVED. IT WAS STATED INTERVENTION WAS TO BE DETERMINED AND THE PATIENT STATUS WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358378 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR