BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4123598 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17847
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 5, 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
    KS, 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 3387S-40, LOT# V553429, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION; PRODUCT ID 37085-95, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3387S-40, LOT# V657037, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A SUDDEN LOSS OF THERAPEUTIC EFFECT THE DAY PRIOR TO REPORT. THE SYMPTOMS WERE REPORTED AS SUDDEN. THEY WERE WRITING CHECKS AND SUDDENLY THEY COULD NOT READ HIS WRITING. THE PATIENT TRIED TO USE THE PATIENT PROGRAMMER BUT THEY SAW ¿WEIRD SCREENS.¿ SINCE THEN HE HAD CHANGED THE PATIENT PROGRAMMER BATTERIES AND NO LONGER RECEIVED ERRATIC MESSAGES. THEY HAD SIDE EFFECTS. ONE OF HIS IMPLANTABLE NEUROSTIMULATORS (INS) SHOWED ¿ON/OK¿ AND THE OTHER ONLY SHOWED SYMBOLS. THEY WERE ABLE TO SUCCESSFULLY CHANGE THE SETTINGS TO SHOW WORDS. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600051 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR