BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 8958267 · Received September 3, 2019

    Report

    Report Number
    3004209178-2019-16886
    Event Type
    Injury
    Date Received
    September 3, 2019
    Date of Event
    November 26, 2018
    Report Date
    October 8, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER: SERIOUS ADVERSE EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    REVIEW OF THIS EVENT DETERMINED THAT THE SERIOUS INJURY ASSOCIATED WITH THIS PATIENT WAS ALREADY CAPTURED IN MFR REPORT NO. 30075662 37-2019-00205. THIS EVENT REMAINS REPORTABLE DUE TO INFORMATION REGARDING IMPEDANCE VALUES AT IMPLANT, HOWEVER THE EVENT IS REPORTABLE FOR MALFUNCTION, NOT SERIOUS INJURY. 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) OF A CLINICAL STUDY REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR PARKINSON'S DISEASE. IT WAS REPORTED THE PATIENT HAD OUT OF RANGE IMPEDANCES AT 0.7V FOR THEIR RIGHT HEMISPHERE AT IMPLANT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IMPEDANCE INFORMATION: C <(>&<)> 0/8 - <(><<)>5171 C <(>&<)> 2/12 - <(><<)>2169 C <(>&<)> 3/11 - <(><<)>2412 0/8 <(>&<)> 1/9 - <(><<)>6398 0/8 <(>&<)> 2/10 - <(><<)>6933 0/8 <(>&<)> 3/11 - <(><<)>7416 1/9 <(>&<)> 3/11 - <(><<)>4519 2/10 <(>&<)> 3/11 - <(><<)>4035 ADDITIONAL INFORMATION RECEIVED FROM AN HCP OF A CLINICAL STUDY VIA A REP LISTED UPDATED IMPEDANCE INFORMATION FROM A (B)(6) 2019 CLINIC VISIT. THE IMPEDANCE TEST WAS RUN AT 1.5V FOR THE RIGHT HEMISPHERE LEAD. NO ACTIONS WERE TAKEN AND THE EVENT WAS CONSIDERED ONGOING. IT WAS FURTHER NOTED THE PATIENT'S DEVICE WAS ABANDONED AND TURNED OFF DUE TO A REPORTED SERIOUS ADVERSE EVENT. IMPEDANCE INFORMATION: C AND 0/8 5171 C AND 1/9 1998 C AND 2/10 2169 C AND 3/11 2412 0/8 AND 1/9 6398 0/8 AND 2/10 6933 0/8 AND 3/11 7416 1/9 AND 2/10 3657 1/9 AND 3/11 4519 2/10 AND 3/11 4035.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP INDICATING THE PATIENT WAS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750011 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| O