BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2841938 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-10627
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 25, 2012
    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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# V813689, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# V813689, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF THE PATIENT'S DEVICE POCKETS WAS SWOLLEN. IT WAS NOTED THAT THERE HAD ALWAYS BEEN A BUMP, BUT THE SWELLING HAD GOTTEN WORSE. IT WAS ALSO NOTED THAT "IT WAS NOT PUT IN RIGHT." IT WAS FURTHER REPORTED THAT THE POCKET IS HOT AND THE PATIENT'S RIGHT HAD WAS "A LITTLE STIFF." IT WAS ALSO NOTED THAT OTHER THAN THE ABOVE ISSUES THE PATIENT'S THERAPY WAS "GOING WELL" AND HIS TREMORS WERE UNDER CONTROL. APPROXIMATELY A MONTH LATER IT WAS REPORTED THAT THE DEVICE IN THE PATIENT'S LEFT SIDE WAS STICKING OUT. IT WAS NOTED THAT THE PATIENT HAD GONE TO THE HOSPITAL ON (B)(6) 2012 BECAUSE OF HIS DEVICE. IT WAS FURTHER REPORTED THAT IT WAS 'ALL RED" UNDER THE BATTERY PACK. IT WAS NOTED THAT THE PATIENT WAS TESTED FOR INFECTION WHILE IN THE HOSPITAL AND IT WAS DETERMINED THAT IT WAS NOT INFECTED. IT WAS ALSO REPORTED THAT THE HEALTH CARE PROVIDER (HCP) "NOTICED THE BATTERY PACK WAS PLACED WRONG." IT WAS ALSO NOTED THAT THE PATIENT'S THERAPY WAS STILL WORKING AND THAT "THIS THING WAS A STEADY AS A ROCK" AND "IT WORKED LIKE CLOCKWORK." IT WAS ALSO NOTED THAT HCP HAD TOLD THE PATIENT THAT THE DEVICE NEEDED TO BE REMOVED OR "YOU WILL CONSTANTLY BE IN HERE WITH THE THREAT OF INFECTION." IT WAS ALSO NOTED THAT "THE WHOLE BATTERY PACK IS STICKING OUT, IT WAS LIKE HE HAD A BREAST HANGING OVER HIS RIGHT NIPPLE, IT WAS VERY PRONOUNCED." IT WAS ALSO REPORTED THAT THE DEVICE "STARTED STICKING OUT THE DAY HE HAD IT DONE" AND "IT JUST GOT WORSE." THE RIGHT SIDE HAD GOTTEN BETTER BUT THE PATIENT HAD BEEN TOLD BY HIS HCP "IT WAS STILL NOT GOOD, IT WAS NOT DONE RIGHT." IT WAS REPORTED "THE RIGHT SIDE IS NOT IRRITATING HIM OR GETTING RED OR BLACK." IT WAS UNCLEAR IF THE PATIENT WAS HAVING ISSUES WITH ONE OR BOTH OF THEIR IMPLANTED DEVICES AND WHICH SYMPTOM PERTAINED TO WHICH DEVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE EVENT PERTAINED TO THE PATIENT'S LEFT SIDE DEVICE. AS THIS REPORT IS FILED ON THE PATIENT'S RIGHT SIDE DEVICE, PLEASE REFER TO MANUFACTURER REPORT #3004209178-2012-10632.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization