BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4200334 · Received October 24, 2014

    Report

    Report Number
    3004209178-2014-20357
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Report Date
    October 2, 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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387S-40, LOT# V170161, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V123174, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS HAVING A ¿HARD TIME¿ WITH THE DEVICE AND WAS GETTING HORRIBLE RESULTS. THE PATIENT NEVER HAD THERAPEUTIC EFFECT AND THE PATIENT¿S THERAPY HAD BEEN ¿EIGHT AND A HALF YEARS OF PURE ABSOLUTE HELL.¿ THE PATIENT STATED THAT AFTER HE MOVED HE WENT TO A NEW CLINIC WHERE THEY KEPT THE SAME SETTINGS AND ¿IT WAS A JOKE.¿ EVEN THOUGH THE SETTINGS WERE NOT CORRECT, THEY REFUSED TO CHANGE THEM. THE PATIENT SWITCHED TO A NEW CLINIC AND THEY CHANGED HIS SETTINGS TWO DAYS PRIOR TO THE REPORT. IT WAS REALLY GOOD THE DAY THEY MADE THE ADJUSTMENT, BUT THE FOLLOWING DAY THE PATIENT STARTED SHAKING WORSE THAN HE EVER SHOOK BEFORE. THE PATIENT COULD NOT CARRY HIS DINNER PLATE OVER TO THE TABLE AND THE DAY PRIOR TO THE REPORT HE COULD NOT PUT ANYTHING IN THE MICROWAVE. THE PATIENT CALLED THE CLINIC AND MADE THEM AWARE. THE CLINIC WANTED TO DO A BRAIN MRI. THE PATIENT NOTED THAT HE NEVER ONCE EXPERIENCED NO TREMORS WITH THERAPY. IT WAS LATER REPORTED THAT SINCE THE SECOND IMPLANT THE PATIENT HAD HAD NOTHING BUT TROUBLE. THE PATIENT HAD SHAKING PROBLEMS AND THE SYSTEM WAS NOT WORKING. THE PATIENT STILL HAD TREMENDOUS SHAKING AND EVERY TIME AN ADJUSTMENT WAS DONE IT WOULD LAST A WHILE BUT THEN WENT BACK. THE ADJUSTMENTS DID NOT HOLD. THE PATIENT WAS NOT HAPPY WITH THE SYSTEM. PATIENT HAD HAD SYMPTOMS SINCE THE SECOND IMPLANT WAS DONE. THE PATIENT HAD HAD TROUBLES EVER SINCE AN EMERGENCY SURGERY. THE PATIENT WAS STILL NOT GETTING SHAKING RELIEF AFTER GENERATOR REPLACEMENT FOR AN UNRELATED ISSUE. THE PATIENT WAS SCHEDULED TO SEE THE HEALTHCARE PROFESSIONAL IN (B)(6) FOLLOWING THE DATE OF THIS REPORT. THE PATIENT HAD SEEN THEIR HEALTHCARE PROFESSIONAL FOR THE PAST 3 WEEKS PRIOR TO THE DATE OF THIS REPORT DUE TO THE PATIENT¿S SHAKING AND THE DEVICE HAD NOT HELD THE CHANGES THAT WERE BEING MADE. NO INTERVENTIONS OR OUTCOME WERE REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY, BUT THEY WERE WORKING WITH THEIR HEALTHCARE PROFESSIONAL (HCP) OR A MANUFACTURING REPRESENTATIVE. THE PATIENT HAD AN APPOINTMENT WITH THEIR HCP ON (B)(6) 2014. AT THE APPOINTMENT, THE PATIENT¿S HCP DETERMINED THE CAUSE OF THE EVENT AND IT WAS NOT DEVICE RELATED. THE PATIENT DID NOT EXPERIENCE A LOSS OF STIMULATION AND THEY WERE REPROGRAMMED. NO TROUBLESHOOTING, INTERVENTIONS, OR OTHER ACTIONS WERE NOT NEEDED AND THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680125 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR