BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3231094 · Received July 17, 2013

    Report

    Report Number
    3004209178-2013-11878
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    June 20, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387S-40, LOT# V245964, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V214250, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE. IT WAS NOTED THAT THE REPORTER WAS NOTIFIED OF A REPLACEMENT OF THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT THE PATIENT HAD A SHORT AND TWO GROUPS, A AND B. IT WAS NOTED THAT THE VOLTAGE WAS FLUCTUATING BETWEEN 2.6 AND 2.69 VOLTS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT SAW AN ERI TODAY ON THE PATIENT PROGRAMMER. IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE THOUGHT THE SHORT WAS ON THE LEFT DEVICE BUT DID NOT KNOW. IT WAS NOTED THAT THE PATIENT WAS TESTED IN THE CLINIC AND CONTACT PAIR 0 AND 1 WAS THE SHORT. IT WAS NOTED THAT THE PATIENT WAS REPROGRAMMED AROUND THE CONTACT PAIR 0 AND 1 WHICH HAD THE SHORT. IT WAS NOTED THAT THE PROGRAM GROUP A WAS TURNED ON WHICH USED CONTACT PAIR 0 AND 2 AND THUS AVOIDED THE SHORT. IT WAS NOTED THAT THE BATTERY WAS SCHEDULED TO BE REPLACED TOMORROW BUT IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE WAS UNSURE IF THIS NEEDED TO BE DONE OR NOT BASED ON NEW BATTERY VOLTAGE INFORMATION AND THE REPROGRAMMED THERAPY IMPEDANCE. IT WAS NOTED THAT THE BATTERY SHOWED 2.86 VOLTS BUT WAS STILL FLASHING ERI. IT WAS NOTED THAT IT WAS THOUGHT TO BE THE LEFT BATTERY THAT SHOWED THE ERI. IT WAS NOTED THAT APPROXIMATELY 90 DAYS AGO THE PATIENT WAS SEEN AT THE CLINIC AND THERE WAS NOT A SHORT. IT WAS NOTED THAT THEY SUSPECTED THAT MAYBE THE PATIENT FELL AND CAUSED THE SHORT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO ADDITIONAL ACTION HAD BEEN TAKEN. IT WAS NOTED THAT THERE WERE NO KNOWN CAUSES OF THE EVENT, HOWEVER, THE PATIENT FELL SEVERAL TIMES PRIOR TO THE VISIT WHERE THE SHORT WAS DETECTED. IT WAS NOTED THAT IT WAS DECIDED BY THE NEUROSURGEON THAT THE REPLACEMENT SURGERY WAS NOT NECESSARY. IT WAS NOTED THAT THE PATIENT WAS DOING WELL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD OPTED NOT TO HAVE A REPLACEMENT AT THIS TIME. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT SAW AN ERI CALL YOUR DOCTOR SCREEN AND COULD NOT GET PAST IT. IT WAS NOTED THAT THE PATIENT WAS GOING TO CHANGE GROUPS. IT WAS NOTED THAT THERE WAS NO UPDATE ON THE STATUS OF THE ERI AND BATTERY DEPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330787 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR