BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2820873 · Received November 6, 2012

    Report

    Report Number
    3004209178-2012-09947
    Event Type
    Injury
    Date Received
    November 6, 2012
    Report Date
    October 8, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 37651 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID, 37642 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID, 37085-40 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION; PRODUCT ID, 37085-40 LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE EXTENSION; PRODUCT ID, 3387S-40 LOT# V821660, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD; PRODUCT ID, 3387S-40 LOT# V821660, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD; PRODUCT ID, 37603 SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN IMPLANTABLE NEUROSTIMULATOR (INS) AND LEAD REPLACEMENT, IT WAS STATED THERE WAS A "KNICK" IN THE EXTENSION, WHICH WAS LATER SEEN IN THE PATIENT'S MEDICAL REPORT AS "INDENTATION IN THE SILICONE." IT WAS LATER NOTED THAT THE EXTENSION "HAD AN INDENTATION BUT NO VISIBLE DAMAGE." AT THE EXTENSION CONNECTION BEHIND THE EAR, IT WAS STATED THERE WAS A "LUMP" THAT STICKS OUT, WAS SWOLLEN, AND WAS PAINFUL. IT WAS STATED THAT IT MAY BE A "BAD WIRE." BEGINNING THE DAY AFTER REPLACEMENT, THE PATIENT HAD BEEN HOSPITALIZED DUE TO EXPERIENCING "DYSTONIC STORMS" ALMOST EVERY DAY, AS MANY AS 1-3 TIMES PER DAY, LASTING 15-40 MINUTES. WHEN THE PATIENT MOVED, SUCH AS WALKING, SHOWERING, OR BEING ON THE TREADMILL, THE PATIENT EXPERIENCED EPISODES IN WHICH HER BODY "CRAMPS UP, HER NECK PULLS BACK, AND HER OXYGEN LEVELS DECREASE DUE TO HER AFFECTED AIRWAY." THE PRIOR 4-5 DAYS, THE PATIENT'S MEDICATION HAD BEEN DOUBLED WHEN SHE HAD AN EPISODE (2MG TO 4MG OF ATIVAN). IT WAS ALSO REPORTED THAT AFTER AN EPISODE THE PATIENT PROGRAMMER WOULD SHOW "POOR COMMUNICATION." THE NEXT DAY IT WAS REPORTED, THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. PRIOR TO THE REPLACEMENT, THE PATIENT'S THERAPY WAS REALLY GOOD AND PATIENT WAS FUNCTIONAL. AFTER THE REPLACEMENT, THE PATIENT HAD THE MULTIPLE DYSTONIC STORMS. IT WAS STATED "THEY CAN MAKE THE DYSTONIC STORM HAPPEN IF SHE WALKS A LONG TIME OR GETS ON THE TREAD MILL." THE PATIENT DID NOT HAVE THE DYSTONIC STORMS PRIOR TO THE REPLACEMENT. PRE-OPERATIVE AND POST-OPERATIVE IMPEDANCES WERE CONSISTENT. IT WAS NOTED, THE PATIENT FELT A SHOCKING SENSATION IN HER CHEST, ON THE LEFT SIDE OF THE BODY (THE INS REPORTED IN THIS MANUFACTURER'S REPORT). THE PATIENT FELT THE SENSATION "ONCE OR TWICE OVER A PERIOD OF A DAY OR TWO." 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 THE PATIENT HAD GONE HOME FROM THE HOSPITAL AND WAS DOING BETTER, BUT NOT AS GOOD AS SHE WAS DOING BEFORE THE BATTERY REPLACEMENT. THE HCP FELT THAT THIS WAS DUE TO DISEASE PROGRESSION, AND NOT THE DBS THERAPY. IT WAS NOTED THAT THE PATIENT HAD UNDERGONE NUMEROUS REVISIONS IN THE PAST AND MAY HAVE ANOTHER REVISION TO MOVE THE LEAD IN THE FUTURE, BUT NOTHING HAD BEEN DETERMINED YET. IT WAS ALSO REPORTED THAT A BRAND NEW PATIENT PROGRAMMER WAS TRIED, AND IT DID NOT ALWAYS READ THE DEVICES. THE 8840 PROGRAMMER READ THE DEVICES EVERY TIME. IT WAS DETERMINED THAT DUE TO THE LOCATION OF THE IMPLANTED DEVICES AND THE STRENGTH OF THE TELEMETRY OF THE PATIENT PROGRAMMER, THE PATIENT PROGRAMMER WOULD NOT WORK EVERY TIME. THE PATIENT WAS EDUCATED ON HOW TO MOVE THE PROGRAMMER AROUND TO GET A BETTER SIGNAL AND UNDERSTOOD THAT THE SYSTEM WAS WORKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization