BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2954897 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02484
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    January 22, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3389S-40, LOT# V126057, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    FURTHER FOLLOW UP INFORMATION REPORTED THAT THE HEALTHCARE PROFESSIONALS AND FACILITIES WERE STILL WORKING ON RESOLVING THE REPORTED ISSUES. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS GETTING ¿SOME THERAPY BUT POTENTIALLY NOT FULL THERAPY.¿ IMPEDANCE MEASUREMENTS WERE PERFORMED AND THE VALUES WERE SIMILAR TO PREVIOUSLY REPORTED MEASUREMENTS. THE PATIENT¿S BATTERY WAS CHANGED A YEAR AGO AND IT WAS NOTED THE CALLER THOUGHT ¿PERHAPS SOMETHING GOT BOTCHED THEN, IF SOMETHING GOT OVER-TIGHTENED OR UNDER-TIGHTENED,¿ BUT IT WAS UNCLEAR IF THIS ACTUALLY OCCURRED. AN X-RAY WAS PERFORMED THE DATE OF THIS REPORT WHICH SHOWED THE LEAD CONNECTOR BLOCK WITH THE EXTENSION MIGRATED DOWN THE PATIENT¿S NECK AND THERE WAS SOME BREAKAGE, A POTENTIAL FRACTURE OR TIGHTENING OF THE COIL ON BOTH THE LEAD AND EXTENSION. IT WAS NOTED THE PATIENT DID NOT HAVE ANY FALLS OR TRAUMA. A LONGEVITY CALCULATION WAS PERFORMED WITH THE PATIENT¿S CURRENT SETTINGS (3V, 330 PULSE WIDTH, 120 HERTZ, ELECTRODES 1+, 2-,3- AND THERAPY IMPEDANCES WAS 1685 OHMS) WHICH SHOWED THE LONGEVITY TO ELECTIVE REPLACEMENT WAS 2.65 YEARS AND END OF SERVICE WAS 2.9 YEARS FROM IMPLANT. THE CURRENT BATTERY VOLTAGE WAS 2.77 V.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND HE HAD NOT HAD ¿GOOD THERAPY SINCE THE CHANGE OUT OF HIS IMPLANTABLE NEUROSTIMULATOR (INS)¿ LAST YEAR. IT WAS NOTED THE PATIENT¿S BATTERY WAS CLOSE TO ELECTIVE REPLACEMENT INDICATOR (ERI) STATUS, THE BATTERY VOLTAGE WAS AT 2.62 V. INS BATTERY LIFE CALCULATION WAS PERFORMED WITH THE PATIENT¿S CURRENT SETTINGS (GROUP D ¿ 3 V, 330 PULSE WIDTH, 120 HERTZ, ELECTRODES 1+, 2-, 3-, AND ESTIMATED GROUP IMPEDANCES OF 2100 OHMS) WHICH REVEALED THE LONGEVITY TO END OF SERVICE (EOS) TO BE 3.19 YEARS. IMPEDANCE MEASUREMENTS TAKEN AT 3 V WERE ¿HIGH BUT NOT HIGH ENOUGH FOR AN OPEN CIRCUIT;¿ IMPEDANCES WERE LESS THAN 4 ,000 OHMS. IT WAS ALSO REPORTED THE PATIENT COULD NOT ADJUST STIMULATION AND A ¿CALL YOUR DOCTOR¿ ICON APPEARED ON THE PATIENT PROGRAMMER. WHEN THE MANUFACTURER REPRESENTATIVE INTERROGATED THE PATIENT¿S INS WITH THE PHYSICIAN PROGRAMMER SHE SAW A MESSAGE STATING ¿THERAPY DELIVERY LESS THAN PROGRAMMED SETTINGS.¿ IT WAS NOTED PER THE MANUAL, THIS WAS AN OUT OF REGULATION (OOR) MESSAGE. ADDITIONAL INFORMATION RECEIVED REPORTED NO FURTHER DIAGNOSTICS HAD BEEN PERFORMED AND THE PATIENT¿S PROVIDERS WERE SCHEDULING A FOLLOW UP APPOINTMENT WITH SPECIALISTS; THE PATIENT WAS GOING TO BE SEEN BY A DEEP BRAIN STIMULATION (DBS) SURGEON AND SPECIALISTS WITHIN A MONTH TO INVESTIGATE FURTHER. IT WAS NOTED THEY COULD NOT RECREATE THE ¿CALL YOUR DOCTOR¿ ICON AND IT FUNCTIONED PROPERLY IN THE CLINIC. THE PATIENT WAS RECEIVING THERAPY BUT IT WAS UNKNOWN HOW EFFECTIVE IT WAS SINCE THE MANUFACTURER REPRESENTATIVE HAD ONLY MET THE PATIENT ONCE AND DID NOT HAVE ANYTHING TO COMPARE IT TO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS NOT ABLE TO ADJUST THEIR STIMULATION AND THE PROGRAMMER WAS DISPLAYING THE OUT-OF-REGULATION (OOR) MESSAGE, AS WELL AS THE "CALL YOUR DOCTOR" ICON. IT WAS NOTED THAT THE PATIENT HAD 4 DIFFERENT PROGRAMS AND THE REPORTER WAS UNCERTAIN WHAT STEPS THE PATIENT WAS DOING WHEN HE SAW THE OOR MESSAGE. THE PATIENT HAD BEEN IN FOR REPROGRAMMING ON (B)(6) 2013. IT WAS STATED THAT THE PATIENT HAS HAD SOME RETURN OF SYMPTOMS THAT WERE "GETTING WORSE". IT WAS NOTED THAT THE PATIENT WAS "DOING WELL" IN (B)(6) 2012. THE PATIENT HAD BEEN HIT IN THE FACE WITH A BASEBALL (EYE-BROW AREA), BUT THERE WAS NO DIRECT HIT TO THE CONNECTOR. THE CURRENT IMPEDANCES MEASUREMENTS WERE WITH IN NORMAL LIMITS, BUT THEY VARIED GREATLY. THE IMPEDANCES WERE BETWEEN 700 OHMS - 1200 OHMS AND CHANGES WERE SEEN WHEN THE PATIENT WOULD WALK OR IF THE IMPLANTABLE NEUROSTIMULATOR (INS) AREA WAS PALPITATED. IT WAS STATED THAT THERE COULD BE AN ISSUE. IT WAS STATED THAT CONTACT 1 OR 2 WAS 2800 OHMS. FOUR DAYS LATER IT WAS REPORTED THAT THERE WERE NO MALFUNCTIONS SEEN AND NO CAUSE OF THE ISSUES WAS DETERMINED. AN X-RAY WAS TAKEN AND "NO PROBLEMS WERE DISCOVERED". IT WAS STATED THAT THE PATIENT WAS "DOING WELL AND RECEIVING THERAPY". NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59016 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00014 YR