BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3170747 · Received June 14, 2013

    Report

    Report Number
    3004209178-2013-10404
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    April 24, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3387-40, LOT# J0427852V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING A TINGLING ¿ON THE ENTIRE BODY WHEN SHE WAS LYING DOWN AND ON THE FINGERS.¿ THIS REPORTEDLY STARTED THE WEEK PRIOR TO THE REPORT. IT WAS FURTHER REPORTED THAT THE TINGLING INCLUDES THE RIGHT AND LEFT SIDE OF THE BODY. IT WAS NOTED THAT THE PATIENT DID NOT HAVE A FALL OR TRAUMA. IT WAS ALSO NOTED THAT THE PATIENT WAS IMPLANTED FOR TREMORS FOR THE LEFT SIDE AND WAS GETTING THERAPY ON THE LEFT SIDE. THE PATIENT REPORTEDLY HAD A SETTING CHANGE THE DAY PRIOR TO THE REPORT AND WENT FROM 3.5V TO 3.3V. IT WAS NOTED THAT THE TINGLING HAD GOTTEN WORSE AND THE PATIENT TURNED THE DEVICE DOWN TO 3.2V ON THE DAY OF THE REPORT. IT WAS LATER REPORTED THAT THE PATIENT WAS EXPERIENCING ¿EXCESSIVE STIMULATION.¿ APPROXIMATELY A MONTH LATER IT WAS REPORTED THAT THE PATIENT WAS HAVING DYSKINESIA. IT WAS NOTED THAT THE DYSKINESIA STARTED ABOUT ONE WEEK PRIOR TO THE DATE OF THE REPORT. IT WAS NOTED THAT HER HEALTH CARE PROVIDER RECOMMENDED THAT THE PATIENT GO TO THE NEUROLOGIST. THE PATIENT REPORTEDLY HAD HER PROGRAM CHANGED FROM A TO B BUT THEN THE PATIENT STARTED TO HAVE DYSKINESIA ON THE LEFT SIDE AND THE PATIENT DOCTOR RECOMMENDED THEY SWITCH BACK TO PROGRAM A. IT WAS NOTED THAT THE PATIENT GOT A ¿POUNDING HEADACHE¿ WHEN HE USED THE PATIENT PROGRAMMER. IT WAS ALSO NOTED THAT THE PATIENT¿S TREMOR AND DYSKINESIA RETURNED. THE DEVICE HAD REPORTEDLY BEEN ACCIDENTLY TURNED OFF . THE DEVICE WAS TURNED BACK ON AND THIS RESOLVED THE RETURN OF SYMPTOMS. THE PATIENT WAS INSTRUCTED ON HOW TO CHANGE THE PROGRAM FROM B TO A AND THE PATIENT WAS GOING TO TRY THAT SETTING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271951 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1