BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3497386 · Received December 3, 2013

    Report

    Report Number
    3004209178-2013-21792
    Event Type
    Malfunction
    Date Received
    December 3, 2013
    Report Date
    November 12, 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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU _UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY DEPLETED PREMATURELY. IT WAS NOTED THAT THE BATTERY REACHED END OF SERVICE (EOS). IT WAS NOTED THAT THE PATIENT EXPERIENCED LOSS OF STIMULATION AND THERAPEUTIC EFFECT. IT WAS NOTED THAT THE ACTION REQUIRED AS A RESULT OF THE EVENT WAS REPLACEMENT. IT WAS NOTED THAT ACTION WAS PLANNED, BUT NOT YET TAKEN AND THAT CONTINUED TROUBLESHOOTING WOULD BE PERFORMED TO LOOK FOR A SHORT CIRCUIT OR OTHER PROBLEM. IT WAS NOTED THAT THE PATIENT VISITED THE HOSPITAL ON THE DAY PRIOR TO REPORT AND HAD NO STIMULATION OR THERAPY. IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS INTERROGATED AND SHOWED EOS, BUT STILL HAD 2.87 VOLTS LEFT. IT WAS NOTED THAT THE CLINICIAN PROGRAMMER SHOWED THAT THE INS WAS TURNED OFF ON (B)(6) 2013. IT WAS NOTED THAT THE LAST VISIT WAS (B)(6) 2013. IT WAS NOTED THAT THE SETTINGS WERE 4.0 VOLTS, 90¿S, 200 HZ, 0 POSITIVE AND 1 AND 2 NEGATIVE. IT WAS NOTED THAT THE IMPEDANCE MEASUREMENT ON (B)(6) 2013 WERE ¿LOW 1-2 (54 OHM).¿ IT WAS NOTED THAT THE IMPEDANCE VALUES WERE AS FOLLOWS: 994; 603; 610; 735; 1066; 1074; 1337; 57; 852; 861. IT WAS NOTED THAT THERAPEUTIC IMPEDANCES MEASURED AT 3.0 VOLTS, 90¿S, AND 190 HZ SHOWED LOW IMPEDANCE AND HIGH CURRENT. IT WAS NOTED THAT THE IMPEDANCES THE DAY AFTER REPLACEMENT IN (B)(6) 2013 WERE HIGH WITH C-2 2078 OHM AND C-3 2165 OHM. IT WAS NOTED THAT THE RANGE OF ¿MONOPOLAR¿ MEASUREMENTS WERE 1112-2165 AND BIPOLAR MEASUREMENT 1840-3860. IT WAS NOTED THAT THE THERAPEUTIC MEASUREMENTS AT 1.6 VOLTS, 60¿S, 180 HZ AND 1 NEGATIVE WERE 1035 OHM WITH ¿1,37 MA.¿ IT WAS NOTED THAT THE PATIENT¿S STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY. IT WAS NOTED THAT IT WAS UNKNOWN IF THERE WERE PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE INVESTIGATION WAS ONGOING. IT WAS NOTED THAT THERE WAS NO MORE INFORMATION AT THE TIME OF REPORT. IT WAS FURTHER NOTED THAT THE PATIENT¿S OUTCOME WAS UNKNOWN AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626643 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1