BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 7117030 · Received December 14, 2017

    Report

    Report Number
    3004209178-2017-25975
    Event Type
    Injury
    Date Received
    December 14, 2017
    Date of Event
    December 11, 2017
    Report Date
    February 12, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529762
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR DYSTONIA AND MOVEMENT DISORDERS. IT WAS REPORTED THE PATIENT WAS ADMITTED TO THE ER AND THEY THOUGHT THEIR INS WAS OFF. IT WAS CONFIRMED THE INS WAS ON AND THEY RAN IMPEDANCES. THE THERAPY IMPEDANCE ON THE LEFT SIDE WAS 321 OHMS. THE THERAPY IMPEDANCE HAD PROGRESSIVELY BEEN DECREASING OVER THE PAST SEVERAL PROGRAMMING SESSIONS WITH THE DOCTOR. THE THERAPY IMPEDANCE VALUES FROM THE PREVIOUS 3 INTERROGATIONS WERE 421 OHMS, 448 OHMS, AND 464 OHMS. THE CALLER HAD IMPEDANCES FROM BEFORE THE SC WAS REPLACED WITH AN RC. THE IMPEDANCES PROVIDED WERE C0 828 C1 829 C2 850 01 1394 OHMS AND O2 1522 OHMS. THE DOCTOR WILL PROBABLY PERFORM SOME TYPE OF INTERVENTION BUT NOTHING WAS CURRENTLY SCHEDULED. THE CALLER THOUGHT IT WOULD LIKELY BE THIS WEEK. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    FOLLOW-UP INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) VIA THE REP REPORTING THAT THE HCP SAW THE PATIENT A FEW WEEKS AGO AND THEY WERE DOING BETTER. THE HCP REPORTED THAT THE PATIENT'S IMPEDANCES WERE 546 OHMS ON THE LEFT, AND 836 OHMS ON THE RIGHT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REP REPORTING THAT SURGICAL INTERVENTION WAS PLANNED BUT NOT SCHEDULED YET TO RESOLVE THE IMPEDANCE ISSUES. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895712 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00643169529762

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention