BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3162680 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10149
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 16, 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
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3389S-40, LOT # V750324, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT # V750324, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37085-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS CONFIRMED THAT THE PATIENT WAS GOING TO CONTINUE HIS RADIATION TREATMENTS. HE WAS ABLE TO CLEAR THE PORS, THAT OCCUR HOURS AFTER HIS TREATMENTS, WITH HIS PATIENT PROGRAMMER. HE HAS HAD OTHER TREATMENTS WITH HIS DEVICE REMAINING ON WITH NO POR MESSAGES. THE WEEK OF (B)(6) 2013 A POR OCCURRED WITH AN EXCLAMATION POINT AND WAS CLEARED, SO HE HAS 8 NEW CHANCES TO CLEAR OUT FUTURE PORS WITH HIS PATIENT PROGRAMMER. HIS LAST RADIATION TREATMENT WILL BE DURING THE WEEK OF (B)(6) 2013. HE WAS DOING FINE REGARDING HIS PARKINSON¿S SYMPTOMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS GOING THROUGH RADIATION TREATMENT FOR PROSTATE CANCER. IT WAS STATED THEY WERE USING ¿SOME FORM OF EXTERNAL RADIATION.¿ IT WAS STATED THAT LATER ON THE NIGHT PRIOR TO REPORT, THE PATIENT¿S SYMPTOMS CAME BACK. THE DEVICE WAS CHECKED AND A POWER-ON-RESET (POR) WAS NOTED. FOUR DAYS LATER IT WAS REPORTED THE ISSUE WAS RESOLVED. THE POR WAS CLEARED WHEN THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS CHECKED. THE ORIGINAL SETTINGS WERE BACK ON AND SYMPTOMS WENT BACK TO NORMAL LEVELS, CONTROLLED WELL BY THE DEEP BRAIN STIMULATOR SYSTEM. IT WAS LATER REPORTED DURING THE RADIATION PROCEDURE THE PATIENT¿S INSS WERE SHIELDED, WITH WHAT THE REPORTER WAS GUESSING WAS LEAD. IT WAS NOTED THE PATIENT HAD THEIR TREMORS COME BACK. ON (B)(6) 2013, A POR WAS CLEARED USING THE PATIENT PROGRAMMER. APPROXIMATELY 2 WEEKS AFTER INITIAL REPORT, IT WAS REPORTED THE PATIENT HAD BEEN UNDER TREATMENT FOR ¿A LITTLE OVER A FEW WEEKS¿ AND THE PATIENT HAD TO HAVE THEIR BRAIN STIMULATOR ¿RESET A FEW TIMES.¿ IT WAS NOTED A LEAD APRON WAS PLACED OVER THE BRAIN STIMULATOR, BUT THE PATIENT WAS STILL GETTING A REACTION FROM THE DEVICE. IT WAS NOTED THE PATIENT ALSO HAD A PACEMAKER AND A MAGNET WAS PUT OVER THE PACEMAKER. IT WAS FURTHER STATED THAT A POR HAD OCCURRED 2 OR 3 TIMES SINCE RADIATION TREATMENT BEGAN. THE NEXT DAY, IT WAS REPORTED THE PATIENT WAS GETTING A POR ALMOST EVERY TIME. IT WAS STATED ONE TIME THE PATIENT DID NOT GET A POR. THE MANUFACTURER¿S REPRESENTATIVE CLEARED A POR THAT HAD OCCURRED AFTER A TREATMENT ON (B)(6) 2013. IT WAS REPORTED THE DEVICE WAS PROGRAMMED TO ALLOW THE PATIENT TO GO DOWN TO ZERO VOLTS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT STIMULATION WAS NOT ABLE TO BE ADJUSTED. IT WAS NOTED THAT THE DISPLAY WAS SHOWING ¿CALL YOUR DOCTOR¿ ICON. IT WAS NOTED THAT THERE WAS A POR CONDITION. IT WAS FURTHER NOTED THAT THERE WAS A WARNING POR SCREEN. IT WAS NOTED THAT THEY HAD BEEN ABLE TO CLEAR POR¿S IN THE PAST BUT THAT THIS ONE CAME UP ON THE DAY OF REPORT. IT WAS FURTHER NOTED THAT THE INS NEEDED TO BE INTERROGATED WITH A PHYSICIAN PROGRAMMER TO CLEAR THE POR. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD RADIATION TREATMENT EVERY DAY UNTIL THE END OF JULY. IT WAS NOTED THAT THE PATIENT BELIEVED THAT THE POR DID NOT OCCUR RIGHT AWAY AND THAT THEY HAPPENED 1 HOUR FOLLOWING THE TREATMENT. IT WAS NOTED THAT THE PATIENT DID NOT HAVE THE IMPLANT OFF DURING TREATMENT COURSE. IT WAS NOTED THAT THE PATIENT COMPLAINED THAT THE MANUFACTURER SHOULD DO A BETTER JOB CHARACTERIZING RADIATION TREATMENT AND THE EFFECT IT HAD ON THE NEUROSTIMULATOR. IT WAS REPORTED THAT THERE WAS A POR CONDITION. IT WAS REPORTED THAT THE CODE SEEN ON THE CLINICIAN PROGRAMMER WAS 0X400 POR. IT WAS NOTED THAT THE MESSAGE APPEARED FOLLOWING EMI EXPOSURE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE POR¿S ARE TYPICALLY PARITY POR¿S. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE STIMULATION IS TURNING OFF. IT WAS NOTED THAT THIS WAS FOLLOWING SOME TYPE OF ENVIRONMENTAL EXPOSURE. IT WAS NOTED THAT THE PATIENT HAD BEEN UNDERGOING RADIATION THERAPY TREATMENTS AND THE DEVICE HAS BEEN TURNING OFF ON AVERAGE TWICE A WEEK. IT WAS FURTHER NOTED THAT THE INS WAS INADVERTENTLY TURNING OFF. IT WAS NOTED THAT THIS STARTED HAPPENING A COUPLE OF DAYS AFTER THE PATIENT STARTED RADIATION THERAPY TREATMENTS. IT WAS NOTED THAT THE PATIENT KNEW THE DEVICE WAS OFF BY A RETURN OF TREMOR AND FEELING SOMETHING DIFFERENT. IT WAS NOTED THAT RADIATION WAS BEING DIRECTED AT PROSTATE. IT WAS NOTED THAT THEY WERE USING A LEAD SHIELDING APRON ON THE FRONT AND BACK SIDE. IT WAS FURTHER NOTED THAT NORMAL X-RAY IMAGING GUIDANCE WAS BEING USED BEFORE AND DURING TREATMENT. THE REPORTER STATED THAT THE ACCUMULATED RADS WERE 3780. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS UNKNOWN IF THE PATIENT TURNED OFF THEIR INS DURING RADIATION TREATMENT. IT WAS NOTED THAT THE MANUFACTURING REPRESENTATIVE WAS GOING TO MEET PATIENT TOMORROW TO HAVE PATIENT TURN OFF IMPLANT PRIOR TO RADIATION. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURING REPRESENTATIVE MET WITH THE PATIENT ON THE DAY OF REPORT AND TURNED THE PATIENT¿S IMPLANT OFF. IT WAS NOTED THAT THE PATIENT WAS ABLE TO TURN STIMULATION BACK ON WITHOUT A POR PRESENT. IT WAS NOTED THAT PREVIOUSLY THE POR WOULD OCCUR LATER ON IN THE DAY BUT SO FAR NO POR HAD BEEN PRESENT AFTER THE RADIATION TREATMENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID TURN STIMULATION OFF FOR ONE OF THE LATEST TREATMENTS BUT THAT THEY GOT A POR ABOUT 2 HOURS AFTER TREATMENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCED SLOWNESS, RIGIDITY, AND MENTAL FATIGUE WHEN OFF. IT WAS NOTED THAT THE PATIENT¿S DEVICE GOES TO POR SEVERAL HOURS AFTER RADIATION TREATMENT EVERY DAY. IT WAS NOTED THAT AT THE TIME OF REPORT THAT THE PATIENT HAD ANOTHER MONTH OF RADIATION TREATMENTS AND THAT HIS STATUS WAS BEING ASSESSED ON A DAILY BASIS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION. IT WAS NOTED THAT THE PATIENT HAD EXPERIENCED A SURGE OF ELECTRICITY WHEN HE CLEARED A POR. IT WAS FURTHER NOTED THAT THE PATIENT WAS ABLE TO ADVANCE TO THE HOME SCREEN WITH THE INS AND THE BATTERY WAS ¿OKAY.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP) REPORTED THAT THE PATIENT WAS GETTING RADIATION THERAPY 3 TIMES A WEEK DUE TO PROSTATE CANCER. EVERY 3RD OR 4TH SESSION THE RADIATION LIMIT WOULD BUILD UP IN THE DEVICE AND IT WOULD POWER ON RESET (POR). THE REP WOULD GO IN AND CLEAR THIS WITH THE CLINICIAN PROGRAMMER (CP). IN-BETWEEN THE RADIATION SESSIONS, STIMULATION WOULD ALSO TURN OFF AND THE PATIENT COULD TURN IT BACK ON USING HIS PROGRAMMER.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW INDICATED THERE WAS NO ALLEGATION THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION. IT WAS ONLY REPORTED THE PATIENT WAS TRYING TO CLEAR A POWER ON RESET (POR) MESSAGE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS A POWER ON RESET (POR) CONDITION FROM ¿RADIATION TREATMENTS TO PROSTATE.¿ THIS HAD OCCURRED IN THE PAST. THE POR NEEDED TO BE CLEARED WITH THE CLINICIAN PROGRAMMER AFTER ABOUT 8 RADIATION SESSIONS. THE PATIENT WAS SHOWN HOW TO CLEAR IT WITH THE PATIENT PROGRAMMER. IT WAS FURTHER REPORTED THE PREVIOUS PORS HAD BEEN REPORTED AND THERE HAD BEEN NO PORS FOR THE PATIENT REGARDING THEIR NEW ROUND OF RADIATION TREATMENT. NO ERROR CODES ACCOMPANIED THE POR AND THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS. THE PATIENT HAD THEIR SECOND TREATMENT ON THE DAY OF REPORT BUT THEY HAD NOT HEARD HOW THEY WERE DOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262628 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR