BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3594784 · Received January 28, 2014

    Report

    Report Number
    3004209178-2014-01257
    Event Type
    Malfunction
    Date Received
    January 28, 2014
    Date of Event
    July 26, 2012
    Report Date
    June 10, 2019
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3387S-40, LOT# V049666, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V042343, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 64002, LOT# N341119, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ADAPTER. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) EXPERIENCED A SUSPECTED OVERDISCHARGE. IT WAS STATED THE PATIENT EXPERIENCED TELEMETRY ISSUES. IT WAS NOTED IT WAS UNKNOWN WHEN THE PATIENT HAD LAST RECHARGED OR RECEIVED THERAPY. THE REPORTER BELIEVED IT HAD BEEN A SIGNIFICANT AMOUNT OF TIME. IT WAS REPORTED THE INS WAS UNDERGOING A PHYSICIAN MODE RECHARGE (PMR) AT THE TIME OF RE PORT. LATER, ON THE DAY OF INITIAL REPORT, IT WAS REPORTED THAT IT HAD BEEN THREE TO FOUR MONTHS SINCE THE PATIENT HAD USED THE SYSTEM. AFTER TWO AND A HALF HOURS OF CHARGING IT WAS NOTED THE PATIENT¿S INS WAS NOT YET A QUARTER CHARGED. FIVE DAYS LATER, ADDITIONAL INFORMATION STATED THE PATIENT HAD FAILED TO RECHARGE THE INS FOR 80 DAYS. IT WAS REPORTED THE PATIENT HAD EXPERIENCED TOURETTE¿S SYMPTOMS. IT WAS NOTED AN OVERDISCHARGE WAS CONFIRMED. IT WAS ALSO NOTED THAT A POWER ON RESET (POR) WAS CLEARED AND THE PATIENT HAD ¿NORMAL FOLLOW-UP WITH HER PHYSICIAN.¿ IT WAS STATED THAT AT THE TIME OF FOLLOW-UP, THE PATIENT WAS RECEIVING ¿EFFECTIVE¿ THERAPY. NO FURTHER INTERVENTIONS WERE PLANNED AS OF FIVE DAYS AFTER THE INITIAL REPORT. A SUPPLEMENTAL REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE PATIENT HAD THEIR IMPLANT WAS OFF FOR THE LAST 5 YEARS. THEY LET IT DIE BECAUSE IT WASN'T HELPING WITH THEIR TOURETTE'S SYNDROME. IT WAS REVIEWED THAT THEY WOULD HAVE TO PERFORM PRM TO CLEAR THE POR SCREEN. THE SCREEN WOULD CLEAR WHEN THE BATTERY IS AT 25% CHARGE. ADDITIONAL INFORMATION FROM THE REP WAS RECEIVED: IT WAS REPORTED AFTER 2 PRM SESSIONS THE REP WAS CURIOUS WHAT MORE NEEDED TO BE DONE. TECHNICAL SERVICES CONFIRMED THAT THEY NEEDED TO DO MORE PRM'S, ESPECIALLY SINCE THE PATIENT HASN'T CHARGE IN 5 YEARS. IT WAS REVIEWED THAT THE PATIENT CAN'T USE STIMULATION UNTIL THE POR SCREEN HAS CLEARED. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THE POWER ON RESET (POR) DID RESOLVE, BUT THE BATTERY WAS UNABLE TO HOLD A CHARGE MORE THAN A FEW MINUTES AND WOULD EXIT THE SESSION. THE REP. STATED THE DEVICE WOULD BE FULLY CHARGED SHOWING SPRITES ON THE RECHARGING SCREEN, SO THE REP. IMMEDIATELY INTERROGATED THE DEVICE AND WAS ABLE TO CLEAR THE POR. IMPEDANCES WERE CHECKED WHICH WERE ALL WITHIN NORMAL LIMITS. THE DEVICE APPLICATION WOULD THEN SHOW A NOTIFICATION THAT THE BATTERY WAS DEPLETED AND NEEDED TO BE CHARGED BEFORE THEY COULD PROCEED, AND WOULD IMMEDIATELY END THE SESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60593 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR