BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5237256 · Received November 19, 2015

    Report

    Report Number
    3004209178-2015-23125
    Event Type
    Injury
    Date Received
    November 19, 2015
    Report Date
    October 27, 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: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 387S-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: 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# N295390, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ADAPTER. (B)(4).

    Description of Event or Problem · 1

    A CONSUMER WHOSE INDICATION FOR USE IS PARKINSON'S DUAL AND MOVEMENT DISORDERS REPORTED THAT AN ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE WAS RECEIVED ON THE NIGHT PRIOR TO THIS REPORT. IT WAS STATED THAT THE ERI MESSAGE WAS SEEN WHILE ADJUSTING THE PATIENT'S VOLTAGE BECAUSE IT WAS THOUGHT THAT THE PATIENT NEEDED UPPING JUST A LITTLE BIT. IT WAS STATED THAT THE PATIENT WAS AT 4.9 VOLTS ON THE RIGHT SIDE AND 4.3 VOLTS ON THE LEFT. IT WAS STATED THAT STIMULATION HAD ONLY BEEN ADJUSTED ABOUT TWO TIMES SINCE IMPLANT AND IT HAD BEEN OVER SIX MONTHS SINCE THE STIMULATION HAD BEEN ADJUSTED/ THE PATIENT PROGRAMMER (PP) HAD BEEN LOOKED AT. IT WAS STATED THAT THE EXACT TIME THAT THE ERI STARTED WAS UNKNOWN. IT WAS STATED THAT THE PATIENT'S HEALTHCARE PROVIDER HAD SAID THE IMPLANTABLE NEUROSTIMULATOR (INS) SHOULD LAST FOUR TO FIVE YEARS. IT WAS NOTED THAT THE PATIENT'S NEXT APPOINTMENT WITH HIS HEALTHCARE PROVIDER WAS SCHEDULED FOR (B)(6) 2014. ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT WAS DOING OKAY. IT WAS REPORTED THAT THE BATTERY WAS IMPLANTED IN (B)(6) 2012 AND WAS AT ERI IN (B)(6) 2014. IT WAS NOTED THAT THE PATIENT WAS GOING TO HAVE THE BATTERY CHANGED. THE FOLLOWING WAS STATED: L STN 4.8 AND R STN 4.2. THE CONSUMER LATER REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) HAD ONLY LASTED A YEAR. THE PATIENT'S VERY FIRST INS HAD LAST 4 YEARS IN COMPARISON TO THIS ONE. IT WAS NOTED THAT IT WAS HARD ON THE PATIENT TO KEEP HAVING THESE SURGERIES TO REPLACE THE INS. THE INSS 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767795 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention