BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3388117 · Received October 4, 2013

    Report

    Report Number
    3004209178-2013-17497
    Event Type
    Malfunction
    Date Received
    October 4, 2013
    Report Date
    September 6, 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
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37751, SERIAL# UNKNOWN, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3387S-40, LOT# V020895, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V020895, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD, PRODUCT ID: 64002, LOT# N351566, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: ADAPTER. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. IT WAS NOTED THAT THE PATIENT WAS HAVING TROUBLE CHARGING AND ONLY GOT 2-4 BOXES AND HAD TROUBLE CHARGING IT FULL. THE DEVICE WAS PURPOSEFULLY PLACED DEEPER DUE TO THE PATIENT¿S SEIZURES AND SHE THOUGHT HER DOCTOR INFORMED HER THIS WAS WHY SHE WAS HAVING TROUBLE RECHARGING. THE PATIENT SAW HER HEALTH CARE PROFESSIONAL LAST WEEK, THEY WORKED WITH HER, AND DID NOT HAVE ANY ADDITIONAL SUCCESS. THE PATIENT HAD ANOTHER APPOINTMENT TO SEE THE DOCTOR COMING UP. THE PATIENT GAINED A BIT OF WEIGHT DUE TO LYRICA/ONIFY ((B)(6)). IT WAS ALSO REPORTED THAT THE PATIENT WAS SEEING A LOW BATTERY SCREEN ON THE PATIENT PROGRAMMER. THE PATIENT REPLACED THE BATTERIES AND THEN SAW THE POOR COMMUNICATION SCREEN AND REPOSITIONING THE ANTENNA RESOLVED THIS. THE PATIENT COULD FEEL THE STIMULATION TURN OFF AND THERAPY WAS CURRENTLY WORKING. THE DEVICE WAS ON, OKAY AND AT 75%. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD NUMEROUS FALLS AND SEIZURES. THE PATIENT HAD ¿NEVER BEEN ABLE TO CHARGE IT, AND IT TAKES ME 4 HOURS EVERY DAY TO CHARGE IT.¿ IT WAS REVIEWED THAT IF THE PATIENT WAS HAVING FALLS, IT COULD BE THE REASON SHE WAS NOT GETTING VERY MANY COUPLING BOXES AND NEEDED TO BE CHECKED BY HER DOCTOR. IT WAS NOTED THAT THE PATIENT¿S DISPLAY SAID ¿LOW AND ITS ALL THE WAY WHITE¿ AND WHEN THE PATIENT TRIED TO CHARGE IT ¿THE SQUARES AT THE BOTTOM WON¿T CHARGE NO MORE AND A LITTLE BIT OF BLACK IS ALL THAT¿S LEFT ON IT.¿ THIS STARTED THIS PAST WEEKEND. THE PATIENT HAD TO ¿MOVE AROUND DIFFERENT WAYS¿ AND HAD ¿PAIN AND TROUBLE WITH IT EVER SINCE IT WAS PUT IN.¿ IT WAS INDICATED THAT WHEN THE PATIENT HAD SEIZURES SHE WOULD ¿GO DOWN HARD AND GO DOWN BACKWARDS AND HIT TO MY RIGHT SIDE¿ WHERE THE DEVICE WAS LOCATED AND IT WAS STILL HURTING ON THAT SIDE. THE PATIENT WAS CONCERNED ABOUT THE DEVICE BEING OVERDISCHARGED. THE PATIENT FELT ¿IT GOING OFF, THE STIMULATION¿ AND HAD ¿ALWAYS FELT IT¿ SO THE PATIENT DIDN¿T KNOW WHAT THAT MEANT AND NOTED THAT IT FELT REAL WEIRD AND THE PATIENT FELT IT TINGLING WHEN IT WENT OFF, BUT THAT WAS NOTHING NEW TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE DID NOT SEEM TOO DEEP, FELT SLIGHTLY TIPPED AND MOVED AROUND IN THE POCKET. BOTH THE PATIENT¿S RECHARGER AND THE MANUFACTURER REPRESENTATIVE¿S CHARGER WERE USED WITH THE PATIENT¿S DEVICE WITH THE SAME RESULTS, HIGHEST COUPLING WAS TWO BARS. THE ANTENNA LOCATE (AL) FEATURE WAS USED. THE POSSIBILITY OF SURGICAL REVISION WOULD BE DISCUSSED. IT WAS NOTED THAT THE PATIENT WAS TECHNICALLY ABLE TO RECHARGE, IT JUST TOOK HER A LONG TIME TO DO SO. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT AT AN APPOINTMENT ON (B)(6) 2013 AFTER POSITIONING THE PATIENT SEVERAL DIFFERENT WAYS, THE SURGEON WAS CONSULTED FOR AN OPINION ABOUT REVISING THE POCKET FOR THE IMPLANTABLE NEUROSTIMULATOR (INS). AT THE TIME OF THE REPORT THE PATIENT WAS LYING DOWN, THE REPORTER NOTICED 6 BARS ON THE RECHARGER. THE PATIENT PICKED HER HEAD UP TO READ AND "FOR WHATEVER REASON" THE RECHARGER COUPLED. 8 BARS WERE SEEN A FEW TIMES. THE INS WENT FROM 1 BAR TO TWO FULL BARS. IT WAS DECIDED NO ACTION WOULD BE TAKEN AT THAT POINT. ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS COUPLING ISSUES ATTRIBUTED TO THE RECHARGER. THERE WAS NO PATIENT INJURY AND NO HOSPITALIZATION AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION RECEIVED (B)(6) 2013 REPORTED THE PATIENT HAD TO LAY A CERTAIN WAY TO CHARGE. THE PATIENT WAS JUST AT THE DOCTOR'S OFFICE, BUT WHEN SHE GOT HOME TRYING TO CHARGE "IT MOVED AGAIN." THE INS WAS NOT SET SO THE PATIENT COULD CHARGE IT. IT WAS REPORTED IT WORKED GREAT WHEN THE PATIENT WAS "ON A HARD PLACE" LIKE AT A DOCTOR'S OFFICE BECAUSE IT HELD THE INS IN PLACE, BUT A COUCH COULD LET IT TIP OR SOMETHING. THE PATIENT USED TO HAVE A LARGER INS. THE CURRENT INS HAD GOTTEN WHERE IT WENT WAY DOWN INTO THE PATIENT'S BREAST. IT WAS NOTED THE PATIENT WAS "LUCKY" IFSHE GOT 2-4 BARS. IT WAS ALSO NOTED THE PATIENT MAY HAVE THE INS MOVED TO THE OTHER SIDE BECAUSE THERE WAS "NO GAP" OR ANYTHING THERE FROM THE BIGGER INS THAT WAS THERE. IT WAS LATER REPORTED THAT AS OF (B)(6) 2013, THE PATIENT WAS STILL HAVING CONCERNS WITH HER DEVICE OR THERAPY BUT WAS WORKING WITH HER DOCTOR OR MANUFACTURER REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502430 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR