BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4949894 · Received July 29, 2015

    Report

    Report Number
    3004209178-2015-14270
    Event Type
    Malfunction
    Date Received
    July 29, 2015
    Date of Event
    June 1, 2015
    Report Date
    July 7, 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
    OK, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3387S-40, LOT # V012316, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT # V012316, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 64002, LOT # N341117, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ADAPTER; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT SAW AN END OF SERVICE (EOS) ERROR CODE ON THE PATIENT PROGRAMMER. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS OFF/DISABLED AND NO LONGER PROVED THERAPY. THE PATIENT¿S MOTHER USED TO CHECK THE SYSTEM, BUT THEY HAD NOT CHECKED IN A LONG WHILE. THE PATIENT THOUGHT THE INS WAS SUPPOSED TO LAST LONGER, BUT THEY DID NOT SAY HOW MUCH LONGER. THE INS HAD NOT BEEN CHECKED BY THE PATIENT¿S HEALTHCARE PROFESSIONAL (HCP) FOR A LONG TIME. THE PATIENT HAD ADVANCED PARKINSON¿S DISEASE SYMPTOMS THAT HAD GRADUALLY BEEN GETTING WORSE. RECENTLY, THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO SYMPTOMS OF NOT BEING ABLE TO MOVE, TREMORS, AND STROKE LIKE SYMPTOMS. THE PATIENT FIRST NOTICED THE SYMPTOMS GETTING WORSE IN JUNE 2015. 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
    494595 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR