BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5237144 · Received November 19, 2015

    Report

    Report Number
    3004209178-2015-23119
    Event Type
    Injury
    Date Received
    November 19, 2015
    Report Date
    October 26, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# V013793, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 3387S-40, LOT# V013793, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 64002, LOT# N295390, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ADAPTER. 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. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER WHOSE INDICATION FOR USE IS PARKINSON'S DUAL AND MOVEMENT DISORDERS REPORTED THAT THE PATIENT'S CURRENT IMPLANTABLE NEURO STIMULATOR (INS) HAD ONLY LASTED A YEAR, IT HAD BEEN IMPLANTED ON (B)(6) 2014. THE DEEP BRAIN STIMULATOR WAS NO LONGER WORKING. THE PATIENT WAS SCHEDULED FOR AN INS REPLACEMENT ON (B)(6) 2015. IT WAS NOTED THAT IT WAS HARD ON THE PATIENT TO KEEP HAVING THESE SURGERIES TO REPLACE THE INS. THE PATIENT'S VERY FIRST INS HAD LAST 4 YEARS IN COMPARISON TO THEIR CURRENT ONE AND THEIR LAST ONE. THE INS'S DON'T LAST VERY LONG AND IT DRAINED THE BATTERY ON STUFF THE PATIENT DID NOT USE. THE HEALTHCARE PROFESSIONAL NOTED THAT THE INS DRAINED SO QUICKLY BECAUSE THERE WERE PROGRAMS THAT RUN IN THE BACKGROUND THAT THE PATIENT DID NOT USE. IT WAS MENTIONED THAT THE PATIENT WAS A LOW SETTING USER. NO PATIENT SYMPTOMS WERE REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN INFORMATION ABOUT TROUBLESHOOTING, INTERVENTIONS, CAUSE, AND OUTCOME. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767997 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Required Intervention