BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3120637 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-07919
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    April 28, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3387S-40, LOT# V637945, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V637945, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN IMPEDANCE ISSUE WHICH WAS DISCOVERED ON (B)(6) 2012, BY HER HEALTHCARE PROFESSIONAL. NO ACTION WAS TAKEN AT THAT TIME BECAUSE IT WAS NOT BOTHERING THE PATIENT. THE NIGHT PRIOR TO THIS REPORT AND THE MORNING OF THIS REPORT AFTER SHE TOOK HER MORNING MEDICATION AND HAD SLEPT FOR ABOUT A HALF HOUR, THE PATIENT FELT LIKE HER WHOLE BODY WAS ¿CONSTANTLY FULL OF ELECTRICITY." IT WAS NOTED THE PATIENT "STRUGGLED" WITH TURNING HER DEVICE OFF AND STILL HAD THE FEELING AFTER SHE TURNED IT OFF. IT WAS ALSO NOTED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED IN HER STOMACH INSTEAD OF HER CHEST. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT RECEIVED ASSISTANCE FROM HER DOCTOR AND/OR MANUFACTURER REPRESENTATIVE AND HER CONCERNS WERE RESOLVED. IT WAS NOTED THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222159 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1