BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2854390 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-11051
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    November 6, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    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) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT# V741376, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT# V741376, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED SORES, POTENTIALLY FROM AN ALLERGIC REACTION. THE PATIENT WAS TAKING ANTIBIOTICS AND IT WAS STATED THAT SHE WOULD "HAVE TO BE ON THEM ALL THE TIME." IT WAS NOTED THAT THE NEUROLOGIST DID NOT BELIEVE THERE WAS A CONNECTION BECAUSE THE REACTION DID NOT OCCUR UNTIL WELL AFTER IMPLANTATION AND IT WAS FOLLOWING A "LIFE EVENT." IT WAS ALSO REPORTED THAT THE PATIENT WAS HAVING HEIGHTENED DEPRESSION WHILE STIMULATION WAS TURNED ON. ANOTHER REPORT ON THE SAME DAY STATED THAT THE PATIENT DID NOT HAVE THE SORES IN THE MONTHS FOLLOWING THE SURGERY. THE PHYSICIAN STATED THAT THE SORES WERE NOT FROM "REJECTION" BECAUSE THE DEVICE IS NOT A BIOLOGICAL SUBSTANCE. IT WAS ALSO STATED THAT DEPRESSION IS A COMMON SYMPTOM FOR PARKINSON'S. IT WAS NOTED THAT A LEAD WAS IMPLANTED IN THE GLOBUS PALLIDUS INTERNUS. THREE WEEKS LATER, IT WAS REPORTED THAT NO ACTIONS OR TROUBLESHOOTING WERE REQUIRED, BUT THE PATIENT OUTCOME WAS "UNKNOWN AT THIS TIME." NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention