BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5474806 · Received March 2, 2016

    Report

    Report Number
    3004209178-2016-03795
    Event Type
    Injury
    Date Received
    March 2, 2016
    Date of Event
    February 7, 2016
    Report Date
    June 2, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE REP FURTHER REPORTED THAT AT IMPLANT WHEN ON THE TABLE, TESTING SHOWED ALL ELECTRODES WERE WITHIN NORMAL RANGE (1,800OHMS). TWO DAYS AFTER IMPLANT THE NEUROLOGIST PROGRAMMED THE PATIENT WITHOUT ANY ISSUES; THE REP DIDN¿T BELIEVE ANY IMPEDANCE TESTS WERE CONDUCTED. THEN TWO DAYS LATER, THAT WAS WHEN THE REP SAW THE OOR ERROR ON THE PP WHILE DOING EDUCATION WITH THE PATIENT. THE REP DIDN¿T HAVE THEIR CLINICIAN PROGRAMMER WITH THEM SO COULD NOT CONDUCT ANY IMPEDANCE TESTS. THE PATIENT HAD EXTENSIONS 37086-60, SO THERE WOULD HAVE BEEN QUITE A BIT OF EXTENSION COILING IN THE POCKET. THE OOR DIDN¿T REAPPEAR WHEN THE PATIENT TURNED THERAPY BACK. IT WAS NOTED THAT A DIFFERENT PP WAS USED, RESULTING WITH THE SAME MESSAGE. THE PATIENT WAS RECEIVING THERAPY. THE PATIENT HAS TO CHECK HER BATTERY DAILY. IF THE PATIENT CHECKS HER BATTERY BEFORE THE 11AM ALARM SOUND, THEN SHE WOULD SEE THE OOR. IF THE PATIENT WAITS UNTIL THE ALARM WENT OFF AT 11AM, THEN CHECK HER BATTERY, THE OOR MESSAGE DIDN¿T APPEAR. ON (B)(6) 2016 THE NEUROLOGIST MET WITH THE PATIENT FOR HER FIRST FOLLOW UP APPOINTMENT. THE NEUROLOGIST WAS UNABLE TO INCREASE THE AMPLITUDE (CONSTANT CURRENT, PATIENT WAS ON ARO UND 3.2MA). TRIED TURNING IT DOWN TO 0MA AND STARTING AGAIN, BUT IT WOULDN¿T LET HIM INCREASE THE AMPLITUDE AT ALL. AN IMPEDANCE TEST WAS RAN AND FOUND ELECTRODE 8, WHICH THE PATIENT WAS PROGRAMMED ON, WAS OUT OF RANGE. THE TEST WAS RAN AT 0.7V, SO THE RESULT WAS >10 ,000OHMS, NO FURTHER TESTING WAS DONE. THE REP BELIEVED ALL OTHER ELECTRODES WERE WITHIN NORMAL RANGE. THE PATIENT WAS THEN REPR OGRAMMED TO ELECTRODE 9 UNTIL FURTHER NOTICE. THE DEVICE WAS ABLE TO BE PROGRAMMED WITHOUT ISSUE. THE PATIENT WAS NO LONGER GETTING THE OOR MESSAGE SINCE THE REPROGRAMMING TO ELECTRODE 9. THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. HOWEVER, THE NEUROLOGIST AND SURGEON DECIDED TO DO EXPLORATORY SURGERY ON (B)(6) 2016. AN X-RAY WAS PERFORMED AND NOTHING WAS OBVIOUS. THE SURGEON SUSPECTED A CONNECTION ISSUE. TROUBLESHOOTING WILL PERFORMED DURING SURGERY TO DETERMINE THE CAUSE OR TO SEE IF THERE WAS A BREAK IN ONE OF THE COMPONENTS. THE INDICATION FOR USE INCLUDED DYSTONIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO FIND OUT THE RESULTS OF THE EXPLORATORY SURGERY THAT WAS SCHEDULED FOR (B)(6) 2016.

    Description of Event or Problem · 1

    THE COMPANY REPRESENTATIVE (REP) REPORTED THAT WHEN INTERROGATING THE IMPLANTABLE NEUROSTIMULATOR (INS) WITH THE PATIENT PROGRAMMER (PP), THE SCREEN SHOWED OUT OF REGULATION (OOR). THE REP TRIED A NUMBER OF TIMES AND SOMETIMES IT SHOWED OOR AND SOMETIMES IT WENT STRAIGHT TO THE HOME SCREEN OF ON AND OK. IT SEEMED THAT USING THE EXTERNAL PP ANTENNA (37092) CAUSED THE OOR, AS WHEN INTERROGATED WITHOUT THE 37092 THE OOR DIDN'T SHOW. THE REP TOOK THE 37092 AND PLANNED TO INVESTIGATE AND SEND A NEW 37092 TO THE PATIENT. THE REP INSTRUCTED THE PATIENT TO CALL IF IT CONTINUES TO HAPPEN AT HOME. TWO DAYS LATER THE PATIENT CALLED THE REP TO SAY IT HAD OCCURRED AGAIN. THE REP DID SOME RESEARCH AND FOUND IT WAS PROBABLY DUE TO A TELEMETRY OOR, SO THE REP TALKED THE PATIENT THROUGH CHECKING TO CONFIRM IT WAS A TELEMETRY OOR AND NOT AN OUTPUT OOR. THIS WAS CONFIRMED WITH THE TROUBLESHOOTING STEPS: THE PATIENT INTERROGATED THE INS, CLEARED THE OOR WITH NAVIGATION KEY, TURNED OFF INS AND THEN BACK ON AGAIN, THEN TURNED DEVICE BACK ON AND SCREEN WENT STRAIGHT TO ON AND OK. THE REP ASSURED THE PATIENT THAT A TELEMETRY OOR DOES NOT AFFECT THERAPY, AND SHE WAS NOT CONCERNED WITH CLEARING THE OOR ON THE PP TO CHECK THE BATTERY STATUS. NO INTERVENTIONS WERE TAKEN TO RESOLVE THE ISSUE, FURTHER STATED THAT NO SURGICAL INTERVENTION OCCURRED BUT UNKNOWN IF PLANNED. THE PATIENT KNOWS TO PRESS THE NAVIGATION KEY TO CLEAR THE TELEMETRY OOR. THE REP WILL DISCUSS WITH THE PATIENT'S MANAGING PHYSICIAN TO RUN ELECTRODE AND THERAPY IMPEDANCE TESTING AT THE NEXT APPOINTMENT. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THIS REPORT. THE PATIENT WAS ALIVE WITH NO INJURY. THE REP REPORTED THREE WEEKS LATER THAT AFTER RE-PROGRAMMING TO ELECTRODE 9 FROM 8, THE MANAGING PHYSICIAN DECIDED TO CANCEL THE EXPLORATORY SURGERY AND SEE HOW THE PATIENT RESPONDS TO THE RE-PROGRAMMING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE MANAGING NEUROLOGIST REPORTED VIA THE REP THREE MONTHS FROM THE INITIAL REPORT THAT CONTACT 8 WAS NOW WORKING AGAIN. THE PATIENT HAS BEEN REPROGRAMMED ONTO THIS ELECTRODE BUT PLANS TO CREATE A GROUP USING ELECTRODE 8 (GROUP A) AND A GROUP USING CONTACT 9 (GROUP B) IN CASE THE PATIENT ENCOUNTERS AN OOR AGAIN IN THE FUTURE.

    Description of Event or Problem · 1

    THE REP REPORTED THAT THE EXPLORATORY SURGERY WAS CANCELLED AND NOT RESCHEDULED. THE PATIENT WAS REPROGRAMMED TO USE AN IN-RANGE ELECTRODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131985 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00028 YR Required Intervention