BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3827025 · Received May 22, 2014

    Report

    Report Number
    3004209178-2014-09461
    Event Type
    Malfunction
    Date Received
    May 22, 2014
    Report Date
    April 29, 2014
    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
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# V032332, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A4,0 SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V032332, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7436, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: NEU_RECHARGER_ACC, SERIAL# UNKNOWN, PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REPORTER WAS HAVING ISSUES CHARGING THE PATIENT AND JUST NOTED THAT SHE HAD SEEN ¿BATTERY ON THE SCREEN BEFORE.¿ THE REPORTER WAS ASSISTED IN CHARGING THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) AND SHE GOT EIGHT BLACK COUPLING BOXES. THE REPORTER THEN USED THE PATIENT PROGRAMMER TO SYNC WITH THE INS AND INITIALLY SAW ¿ON AND OK.¿ ANOTHER PERSON THEN STATED THAT THEY CHECKED THE INS ¿15 MINUTES AGO AND IT READ OFF AND OK.¿ IT WAS NOTED THAT THE PATIENT HAD A ¿CHANGE OF CONDITION OVER THE PAST WEEKEND.¿ THE REPORTER CLARIFIED THAT THE PATIENT¿S BLOOD PRESSURE WAS UP AND HE WAS AGITATED. IT WAS NOT CLEAR IF THE INS WAS ON OR OFF. THE REPORTER NOTED THAT THE PATIENT WAS MEETING WITH HIS DOCTOR ¿ON MONDAY.¿ ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306198 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1