BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3222398 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-11645
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 18, 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
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389-40, LOT# J0225580V, IMPLANTED: (B)(6) 2005: PRODUCT TYPE LEAD; PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005: PRODUCT TYPE EXTENSION; PRODUCT ID 3389-40, LOT# J0206639V, IMPLANTED: (B)(6) 2005: PRODUCT TYPE LEAD; PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005: PRODUCT TYPE EXTENSION; PRODUCT ID 7436, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005: PRODUCT TYPE PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HADN¿T HAD A REPLACEMENT YET AND THE PATIENT STATED AT AN APPOINTMENT THAT SHE HADN¿T FELT THE TINGLING IN OVER A MONTH.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT ATTEND THE PROGRAMMING CLINIC. IT WAS NOTED THAT THE MANUFACTURING REPRESENTATIVE DID NOT HAVE AN UPDATED STATUS. IT WAS FURTHER NOTED THAT THEY WOULD SEND AN UPDATE WHEN THEY SAW THE PATIENT IN CLINIC NEXT. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELT A ¿ZING¿ ABOUT ONCE A MONTH IN THEIR RIGHT LATERAL NECK AREA. IT WAS NOTED THE ¿ZING¿ DID NOT OCCUR AT THE LEAD/EXTENSION CONNECTION, WHICH WAS RETROAURICULAR. THE REPORTER STATED THE ¿ZING¿ DID NOT BOTHER PATIENT THAT MUCH. IT WAS NOTED THE IMPLANTABLE NEUROSTIMULATOR WAS PLACED IN THE ABDOMEN SINCE THE PATIENT WAS VERY PETITE AND THIN. IT WAS FURTHER NOTED THE PATIENT WAS ¿DOING FANTASTIC¿ ON THE THERAPY. 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 THE VOLTAGE WAS INCREASED AND THE PATIENT FELT MUCH BETTER AFTER THEY LEFT THE DOCTOR'S OFFICE. NO OTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE HIGH IMPEDANCES MEASURING 16057 OHMS ON ELECTRODES C0, 01, 02, 03. IT WAS NOTED THAT PATIENT FELT A ZING BEHIND HER RIGHT EAR NEAR THE EXTENSION, BUT HAD NOT EXPERIENCED THIS IN OVER A MONTH. CONTACT 0 HAD NOT BEEN USED FOR THERAPY AND THERE WERE NO COMPLAINTS OF A LOSS OF THERAPY OR OTHER ISSUES. THE DEVICE CURRENTLY READ ERI (ELECTIVE REPLACEMENT INDICATOR), AND THE PATIENT WAS GETTING A BATTERY REPLACEMENT IN A MONTH OR TWO. IT WAS INDICATED THAT THE PATIENT HAD NOT FELT THE TINGLING SENSATION BEHIND HER RIGHT EAR FOR OVER A MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323498 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR