BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4987797 · Received August 10, 2015

    Report

    Report Number
    3004209178-2015-15673
    Event Type
    Malfunction
    Date Received
    August 10, 2015
    Date of Event
    July 9, 2015
    Report Date
    July 15, 2015
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37651, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 64001, LOT# N446444, IMPLANTED: 2015 (B)(6); PRODUCT TYPE ADAPTER PRODUCT ID 3389S-40, LOT# V043266, IMPLANTED: 2007 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID NEU_PTM_PROG, SERIAL# UNKNOWN; PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    THE MANUFACTURING REPRESENTATIVE REPORTED THAT SINCE THE PATIENT'S DEVICE WAS REPLACED ON (B)(6) 2015 THE PATIENT HAD NOT FELT WELL. IMPEDANCES HAD BEEN FINE POST-OPERATIVELY AND THE PATIENT WAS 100% CHARGED POST-OPERATIVELY ALSO. THE PATIENT'S DEVICE HAD BEEN ON POST-OPERATIVELY BUT ON (B)(6) 2015 THE PATIENT WAS RECHARGING AND HAD USED THE PATIENT PROGRAMMER TO CHECK STATUS AND THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS OFF. (B)(6) 2015 HAD BEEN THE ONLY TIME THE PATIENT HAD USED THE PATIENT PROGRAMMER AND HE HAD HAD A CALL YOUR DOCTOR ICON BUT HAD NOT KNOWN INFORMATION AROUND THE ICON. THE INS HAD TURNED OFF A FEW TIMES AND THE PATIENT WAS NOT TURNING IT OFF USING THE PATIENT CONTROLLER. THE MANUFACTURING REPRESENTATIVE HAD INSTRUCTED THE PATIENT TO TURN THE INS BACK ON. THE MANUFACTURING REPRESENTATIVE WAS GOING TO MAKE ARRANGEMENTS TO SEE THE PATIENT AND INTERROGATE THE DEVICE TO DETERMINE AT WHAT POINT THE PATIENT WAS OFF. THE PATIENT WAS CURRENTLY BETWEEN 50% AND 75% CHARGED. THE PATIENT HAD PARKINSON'S DISEASE. THE PATIENT WAS RECHARGING TOO OFTEN, THE PATIENT HAD GONE TO BED WITH THE CHARGE AT 75% AND WOKEN UP WITH A LOW CHARGE LEVEL BUT IT HAD BEEN UNCLEAR WHAT WAS MEANT BY LOW. IT WAS CLARIFIED THAT THE PATIENT HAD WOKEN UP WITH 25% REMAINING. THE PATIENT WAS QUIZZED AND WAS TOLD TWO DIFFERENT LEVELS AND BELIEVED THEY WERE LOOKING AT THE RECHARGER CHARGE LEVEL OR PATIENT PROGRAMMER CHARGE LEVEL AND NOT THE INS CHARGE LEVEL. THERE WAS A SHORT ON CONTACTS 0 AND 2, IMPEDANCES WAS 8 OHMS. THE PATIENT WAS PROGRAMMED WITH 0+,1+, 2-. THE HEALTHCARE PROFESSIONAL PROGRAMMED DIFFERENT ELECTRODE AND DID NOT PLAN ON A REVISION TO CORRECT THE SHORT. THE PATIENT WAS TURNED OFF AGAIN ON (B)(6) 2015 WHEN HIS WIFE HAD CHECKED HIM BUT IT WAS UNCLEAR IF THE WIFE UNDERSTOOD HOW TO USE THE PATIENT PROGRAMMER. THE PATIENT HAD SEEMED TO BE FEELING BETTER AS OF (B)(6) 2015 BUT HAD COMPLAINED OF OCCASIONAL FLUCTUATIONS IN HIS SYMPTOMS. THE MANUFACTURING REPRESENTATIVE MET WITH THE PATIENT ON (B)(6) 2015 AND THE DEVICE WAS INTERROGATED. THE ISSUE WAS LIKELY RELATED TO DISCHARGE. THE MANUFACTURING REPRESENTATIVE INQUIRED IF THE SHORT WOULD ADD TO THE RECHARGING EVERY DAY AND IT WAS CONFIRMED THAT WOULD BE CORRECT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT HAD BEEN CHARGING 3 HOURS AND WAS ONLY ABLE TO GET THE INS FROM 50%-75% WITH AN AVERAGE COUPLING OF ALMOST 8 BARS. IT WAS NOTED THAT THE PATIENT LEAVES STIMULATION ON. THE PATIENT HAD TO CHARGE EVERYDAY BUT IT WAS NOT CLEAR HOW FULL THE PATIENT ALLOWED THE INS TO GET BUT WAS LATER NOTED THAT THE PATIENT HAD NOT GOTTEN THE INS PAST 50%. THE MANUFACTURING REPRESENTATIVE WALKED THE PATIENT THROUGH THE PROGRAMMER AND SHOWED HIM HOW TO CONFIRM IF HE WAS ON OR OFF AND IT WAS BELIEVED THAT THE PATIENT MAY HAVE UNWITTINGLY TURNED HIMSELF OFF AND THE PATIENT WAS ABLE TO TURN HIMSELF BACK ON. THE PATIENT WAS ADVISED TO SEE HEALTHCARE PROFESSIONAL TO HAVE SYSTEM CHECKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522594 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR