BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3772404 · Received April 25, 2014

    Report

    Report Number
    3004209178-2014-08095
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Report Date
    April 15, 2014
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3387S-40, LOT# VA0C4XS, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# VA0BH4Q, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED ON (B)(4) 2104 THAT THE PATIENT WAS PROGRAMMED ON (B)(6) 2014 AND THEIR TREMOR WAS GOOD FOR ONE DAY BEFORE IT CAME BACK AS BAD AS BEFORE. IT WAS NOTED THE PATIENT HAD TREMOR IN THEIR RIGHT HAND INITIALLY. IT WAS FURTHER NOTED THE PATIENT WENT IN FOR FURTHER PROGRAMMING A WEEK LATER, BUT THE RESULTS WERE THE SAME. THE REPORTER STATED THEY WOULD FOLLOW UP WITH THEIR HEALTHCARE PROFESSIONAL (HCP). IT WAS NOTED THAT THERE WERE NO KNOWN ACCIDENTS OR INCIDENTS RELATED TO THIS COMPLAINT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. THREE DAYS LATER IT WAS REPORTED THAT THE PATIENT WAS SEEN ON (B)(6) 2014 AND THEIR SYMPTOMS HAD DECREASED BY MORE THAN 50%. THE REPORTER STATED THEY FOLLOWED UP WITH THE PATIENT ON (B)(6) 2014 AND THEY WERE DOING WELL. A LITTLE OVER TWO MONTHS LATER IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT STATED THAT SINCE IMPLANT THERAPY HAD BEEN WORKING WELL UNTIL MARCH. THE PATIENT STATED THAT ON A TUESDAY HE WAS MOVING AROUND AND RIDING A BIKE, BUT THEN HE WOKE UP WEDNESDAY AND COULD BARELY WALK. IT WAS CALLED AN ¿OVERNIGHT STOP.¿ THE PATIENT STATED THAT SINCE THEN HE HAD BEEN STRUGGLING TO REPROGRAM. THE PATIENT SAW HIS HCP TWO TO THREE TIMES A WEEK AND WHEN THEY FOUND A PROGRAM IN OFFICE IT ONLY LASTED ONE TO TWO DAYS AND THEN STOPPED AND HE TURNED THE IMPLANTABLE NEUROSTIMULATOR (INS) OFF JUST TO FUNCTION. THE PATIENT STATED THAT AN IMPEDANCE CHECK WAS OK AND THE HCP HAD NOT DONE DIAGNOSTIC TESTING. THE PATIENT ALSO HAD NO FALLS OR TRAUMA AND NO CHANGE IN MEDICATIONS. THE PATIENT STATED THAT HE HAD TO TURN HIS INS OFF THE FRIDAY PRIOR TO THE REPORT BECAUSE IT WOULD NOT FUNCTION AND IT WAS STILL OFF AT THE TIME OF THE REPORT SO THAT HE COULD FUNCTION PROPERLY. THE PATIENT ALSO MENTIONED THAT HE STILL HAD A TREMOR. THE PATIENT HAD AN APPOINTMENT THE WEEK PRIOR TO THE REPORT WHERE THEY DID PROGRAMMING FOR THE TREMOR TO ¿TUNE IT OUT¿ AND ONCE HE STARTED MOVING OR WALKING AROUND THE TREMOR WOULD RETURN ALMOST IMMEDIATELY. IT WAS STATED THAT A MANUFACTURER REPRESENTATIVE WAS NOTIFIED AT THIS APPOINTMENT. THE HCP GAVE THE PATIENT A RANGE OF VOLTAGES HE COULD FLUCTUATE BETWEEN. THE PATIENT STATED THAT FOR ONE WEEK HE TURNED THE VOLTAGE ALL THE WAY UP AND DOWN AND HAD NO RESPONSE OR CHANGE IN SYMPTOMS. THIS OCCURRED ON (B)(6) 2104 AND SINCE THE PATIENT HAD NO RESPONSE AT ALL HE PUT THE THERAPY BACK WHERE IT WAS. THE PATIENT STATED THAT HE HAD AN ENGINEERING BACKGROUND AND TO HIM IT APPEARED THE INS JUST QUIT. THE PATIENT STATED THAT IT WAS FRUSTRATING BECAUSE IT WAS DOING SO WELL, THEN IT WAS ¿LIKE SOMEONE FLIPPED A SWITCH AND IT QUIT.¿ ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD NOT YET BEEN SEEN BY THE NEW HEALTHCARE PROVIDER (HCP). THE PATIENT HAD AN APPOINTMENT SCHEDULED FOR (B)(6) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A LOSS OF EFFICACY, WHICH WAS UNRELATED TO THE STIMULATION THERAPY. THIS ISSUE BEGAN (B)(6). IT WORKED FOR SIX WEEKS AND NOW THE PATIENT WAS WORSE WITH THE DEVICE ON. THE PATIENT HAD THE DEVICE OFF SINCE THE SUNDAY PRIOR TO THE REPORT AND HE WAS BETTER WITHOUT IT. WHEN THE DEVICE WAS TURNED ON THE PATIENT'S ABILITY TO WALK WENT DOWN. THE PATIENT COULD NOT GET THE SYSTEM TO WORK, SO THE HEALTHCARE PROVIDER (HCP) TURNED IT OFF AS IT WAS NOT FUNCTIONING PROPERLY. IT WAS NOTED THAT MANUFACTURER REPRESENTATIVES HAD CHECKED THE DEVICE AND COULD NOT FIND ANYTHING WRONG. THE PATIENT STILL HAD CONCERNS WITH HIS DEVICE AND WAS WORKING WITH HIS HCP. THE PATIENT WAS DUE TO SEE HIS HCP THE WEDNESDAY AFTER THE REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO FURTHER DIAGNOSTICS WERE PERFORMED. NO MALFUNCTIONS WERE SEEN AND THE CAUSE OF THE ISSUE WAS NOT DETERMINED. NO INTERVENTIONS WERE TAKEN OR PLANNED. THE REPORTER DID NOT HOW THE PATIENT WAS DOING. LATER THAT DAY IT WAS REPORTED THAT THE PATIENT'S DOCTOR REFERRED HER TO ANOTHER PHYSICIAN TO SEE IF HE HAD BETTER LUCK PROGRAMMING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A LOSS OF STIMULATION AND THERAPEUTIC EFFECT. THE PATIENT WAS REPROGRAMMED, IMPEDANCES WERE TAKEN, AND A MRI WAS TAKEN. A CYST WAS OBSERVED BY THE DOCTOR UPON REVIEWING THE MOST RECENT MRI. THE CYST WAS ALONG THE LEAD AND NEAR THE ¿HIGHEST CONTACT.¿ THE CYST WAS NOT VISIBLE ON THE PRE-OPERATIVE SCAN. THE PATIENT WAS EXPERIENCING EXCELLENT THERAPY FOR WEEKS FOLLOWING IMPLANT, BUT THERE WAS A CESSATION OF THERAPY DESPITE NUMEROUS PROGRAMMING SESSIONS WITH THE NEUROLOGIST. THE PATIENT HAD LESS THAN 50% THERAPY RELIEF. THE PATIENT OUTCOME WAS NOTED AS ALIVE WITH NO INJURY AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NOT GREATER THAN 50% SYMPTOM REDUCTION. A MRI WAS COMPLETED ON AN UNKNOWN DATE AND THIS WAS THE BASIS FOR DIAGNOSIS. THE IMPEDANCES WERE ALSO TAKEN AND CAME BACK WITH ¿NORMAL RESULTS.¿ THE PATIENT WAS PROGRAMMED SEVERAL TIMES BY A DOCTOR. THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY AND WAS SCHEDULED TO SEE A DIFFERENT DOCTOR FOR PROGRAMMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251971 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1