BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2877079 · Received December 18, 2012

    Report

    Report Number
    3004209178-2012-11970
    Event Type
    Injury
    Date Received
    December 18, 2012
    Report Date
    November 27, 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
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PREVIOUSLY REPORTED CONCLUSION CODES NO LONGER APPLY TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3389S-40, LOT# V050963, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT AFTER GOING TO AN ENT SPECIALIST, THE PATIENT HAD BEEN TOLD THAT SHE HAD HEARING LOSS FOR HIGH PITCHED SOUNDS. IT WAS STATED THAT THE PATIENT WAS HAVING A HARD TIME ¿COMING UP WITH WORDS¿ BECAUSE OF HER PARKINSON¿S. IT WAS FURTHER STATED THAT THE PATIENT HAD NEVER TURNED HER STIMULATOR OFF TO SEE IF THE RINGING IN HER EAR WOULD STOP. IT WAS NOTED THAT THE ONLY TIME THE PATIENT HAD TURNED HER STIMULATION COMPLETELY OFF WAS TO HAVE AN EKG DONE. IT WAS FURTHER NOTED THAT THE PATIENT HAD FOUR SURGERIES DONE IN THE TWO YEARS PRIOR TO THIS REPORT; TWO SURGERIES WERE FOR AN ANKLE FUSION; ONE SURGERY WAS FOR A BATTERY CHANGE; THE LAST SURGERY WAS TO ADD AN ADDITIONAL STIMULATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A CONSTANT NOISE, ALSO DESCRIBED AS A RINGING, IN HER EAR. THE PATIENT STATED THAT IT STARTED "NOT LONG" AFTER THE IMPLANT OF HER MOST RECENT DEVICE. THE PATIENT HAD HER EARS CHECKED IN JULY, BUT NOT MUCH DETAIL WAS GIVEN. THE PATIENT MENTIONED HER LEAD "PROTRUDED" BEHIND HER EAR AND HEARD THE RINGING WHEN THE DEVICE WAS ON AND OFF. THE PATIENT NOTED THAT SHE DID NOT HAVE THE ISSUE BEFORE HER RECENT IMPLANT; SHE HAD THE SAME LEADS AS BEFORE, ONLY THE BATTERY WAS REPLACED. THE PATIENT ALSO BEGAN HAVING VISUAL HALLUCINATIONS THE WEEKEND PRIOR TO THE REPORT AND LOST HER APPETITE. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Other