BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5025933 · Received August 24, 2015

    Report

    Report Number
    3004209178-2015-16577
    Event Type
    Malfunction
    Date Received
    August 24, 2015
    Date of Event
    August 4, 2015
    Report Date
    September 14, 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
    PA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387-40, LOT# J0546383V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID: 3387-40, LOT# V000525, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_PTM_PROG, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL MDR SUBMITTED TO CORRECT THAT ORIGINAL AWARE DATE HAS NOT CHANGED FROM THE INITIAL MDR. IT WAS POPULATED IN THE PREVIOUS SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THE PATIENT HAD A LOSS OF THERAPY AND A LOSS OF STIMULATION. THE PATIENT HAD NOT CHECKED THE IMPLANTABLE NEUROSTIMULATOR (INS) WITH THE PATIENT PROGRAMMER SINCE THEY NEEDED TO FIND BATTERIES FOR THE PROGRAMMER. A CHANGE THE PROGRAMMER BATTERIES SCREEN WAS DISPLAYED ON THE PROGRAMMER. THE INS WAS DOWN BELOW 25 PERCENT AND THE PATIENT HAD BEEN SHAKING ALL MORNING ON (B)(6) 2015. THE INS HAD BEEN SINCE CHARGED UP TO 50 PERCENT. THE PATIENT'S INDICATION FOR USE IS ESSENTIAL TREMOR AND MOVEMENT DISORDERS. 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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT REPORTED THE CIRCUMSTANCES THAT LED TO THE LOSS OF STIMULATION AND SHAKING WAS THAT THEY LET THE BATTERIES GO TOO LOW. THE LOSS OF STIMULATION AND THE SHAKING IN THE MORNING HAD RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558684 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR