BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3211507 · Received July 8, 2013

    Report

    Report Number
    3004209178-2013-11461
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 17, 2013
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 3389-40, LOT# J0421486V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD; PRODUCT ID 3389-40, LOT# J0401952V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION; PRODUCT ID 7436, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT SINCE THE PATIENT HAD A BATTERY REPLACEMENT IN (B)(6) 2010 THE PATIENT HAS EXPERIENCED ¿NOTHING BUT GRIEF WITH IT.¿ IT WAS FURTHER NOTED THAT THE STIMULATOR HAD BEEN REPROGRAMMED MANY TIMES AND EACH TIME THE PATIENT WOULD HAVE GOOD RESULTS FOR ABOUT 8 HOURS OR SO AND THEN IT WOULD ¿GO BACK¿ AND THE PATIENT WOULD BEGIN SHAKING AGAIN. THE PATIENT PROGRAMMER WAS REPORTEDLY USED TO CHANGE THE PATIENT TO PROGRAM B BUT IT ¿WOULD NOT TAKE IT.¿ IT WAS NOTED THAT THE BATTERIES IN THE PROGRAMMER WERE CHANGED AND ¿ALL OF A SUDDEN IT WORKED.¿ IT WAS THEN NOTED THAT IT WENT BACK TO PROGRAM C. THE PATIENT WAS REPORTEDLY BETTER ON PROGRAM C BUT IT WOULD NOT STAY ON PROGRAM C. IT WAS UNCLEAR WHICH PROGRAM THE PATIENT WANTED TO BE ON. IT WAS THEN NOTED THAT THE SYMPTOMS WOULD ¿GO BACK.¿ IT WAS NOT CLEAR IF THE PROGRAM WAS CHANGING BACK AS WELL. IT WAS FURTHER REPORTED THAT WHEN THE SHAKING WAS UNDER CONTROL THE PATIENT HAD TROUBLE WALKING AND TALKING. THE PATIENT WAS REPORTEDLY IN FOR REPROGRAMING ON THE FRIDAY PRIOR TO THE DATE OF THE REPORT AND THE FREQUENCY WAS ADJUSTED. THE PATIENT COULD SPEAK AND WALK BETTER BUT BY SATURDAY MORNING SHE WAS REPORTEDLY BACK TO SHAKING AGAIN. THE PATIENT REPORTEDLY ONLY HAD ONE SIDE DONE AT FIRST AND THEY COULD ¿SPEAK AND WALK GOOD;¿ HOWEVER, AFTER THE SECOND SIDE WAS COMPLETED THAT PATIENT STARTED HAVING TROUBLE SPEAKING AND WALKING. IT WAS NOTED THAT THE SHAKING, SPEAKING, AND WALKING COULD ALL BE CONTROLLED FOR A SHORT TIME BUT THE EFFECT WOULD BE LOST AFTER ABOUT 8 HOURS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN AS THE HEALTH CARE PROVIDER (HCP) BEGAN SEEING THE PATIENT IN 2013. THE PATIENT HAD A REPROGRAMMING APPOINTMENT ON (B)(6) 2013 WITH THE MANUFACTURER REPRESENTATIVE. THE PATIENT HAD IMPROVEMENT IN TREMOR BUT HER DYSARTHRIA AND IMBALANCE WAS UNCHANGED. HOSPITALIZATION WAS NOT REQUIRED AND THE PATIENT OUTCOME WAS NOTED AS NO INJURY. THE HCP SUSPECTED PARKINSON DISEASE PROGRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309772 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR