BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 7643719 · Received June 27, 2018

    Report

    Report Number
    3007566237-2018-01915
    Event Type
    Injury
    Date Received
    June 27, 2018
    Date of Event
    June 13, 2018
    Report Date
    October 3, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3708660, SERIAL#: (B)(4), EXPLANTED: (B)(6) 2018, UBD: 27-SEP-2020, UDI#: (B)(4). 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

    THE EXTENSION (SERIAL NUMBER: (B)(4)) BODY CONDUCTOR WAS BROKEN LESS THAN 5 CM FROM THE PROXIMAL END. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP AND CONFIRMED WITH THE HCP. THE IMPLANT DATE FOR BOTH THE INS AND THE EXTENSION WAS UPDATED. THE SERIAL NUMBER OF THE INS WAS UPDATED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR PARKINSON'S DISEASE. IT WAS REPORTED THAT A PART OF THE PATIENT'S DBS CIRCUIT (PROBABLY #2) HAD HIGH IMPEDANCE OF ABOUT 20,000 OHMS. THE ADAPTOR WAS REPLACED AND THE ISSUE IMPROVED. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. ELECTRODE IMPEDANCES WERE REPORTED (SEE BELOW). C & 0: 2881, C & 1: 2308, C & 2: 20772, C & 3: 2323, 0 & 1: 4345, 0 & 2: 24899, 0 & 3: 4892, 1 & 2: 23237, 1 & 3: 4359, 2 & 3: 23066.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484374 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention