BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4131817 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18056
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 10, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387-40, LOT# V004839, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID 3387-40, LOT# V006127, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4). (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED/REPLACED ON (B)(6) 2014 AND THOUGHT THAT THE PROGRAMMER SAID THE LEFT IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT WORKING. ON SATURDAY PRIOR TO THE DATE OF THIS REPORT THE PATIENT HAD COME HOME AND FELT LIKE ONE OF HIS SIDES WAS NOT WORKING AND SOMETHING HAD NOT FELT RIGHT ABOUT IT. THE PATIENT GOT THE PROGRAMMER OUT ON THE NIGHT PRIOR TO THE DATE OF THIS REPORT. THE PATIENT REPLACED THE PROGRAMMER BATTERIES AND THOUGHT THE PROGRAMMER WAS NOT WORKING. THE PROGRAMMER WAS ACTING UP. THE PATIENT¿S DAUGHTER SYNCED WITH THE INS AND THE PROGRAMMER WAS NOW WORKING. IT WAS NOTED THAT IF THEY SYNC WITH THE FIRST INS AND THEN DON¿T TURN THE PROGRAMMER OFF AND SYNC WITH THE SECOND INS THEY WERE GETTING A POOR COMMUNICATION SCREEN. THESE ISSUES HAD STARTED OVER LABOR DAY PRIOR TO THE DATE OF THIS REPORT. THE PATIENT¿S DAUGHTER SYNCED THE PROGRAMMER WITH ONE INS AND AT ONE POINT IT HAD SAID ONE WAS NOT WORKING AND THE OTHER WAS. THERE WAS NO OUTCOME PROVIDED REGARDING THE EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REFERENCE MANUFACTURER¿S REPORT NUMBER: 3004209178-2014-18052.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612981 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR