BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 8826932 · Received July 25, 2019

    Report

    Report Number
    3004209178-2019-14264
    Event Type
    Injury
    Date Received
    July 25, 2019
    Date of Event
    July 10, 2019
    Report Date
    July 25, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MRU
    UDI-DI
    00643169864191
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE APPROXIMATE. THE MAIN DEVICE DESCRIBED IS NOT APPROVED UNDER PMA/510K # H020007 FOR THE DESCRIBED INDICATION: DYSTONIA (PRODUCT CODE: MRU). OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: EXTENSION; PRODUCT ID: 3387S-40, LOT# VA0NG8Z, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: LEAD; PRODUCT ID: 3387S-40, SERIAL/LOT #: (B)(4), UBD: 14-JUL-2017, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR DYSTONIA, MOVEMENT DISORDERS, AND DBS (DEEP BRAIN STIMULATION) THERAPY INDICATIONS. IT WAS REPORTED THAT THERE WAS AN INFECTION CONFIRMED AT THE INCISIONAL WOUND OPENING OF THE LEAD, AND THE WIRE WAS STARTING TO STICK OUT. THE PATIENT RECEIVED BACTRIM - ORAL ANTIBIOTIC TO TAKE AND BELIEVED SHE WAS GIVEN THE ANTIBIOTIC WHILE IN THE HOSPITAL DUE TO THE PROCEDURE. THE PATIENT DID NOT BELIEVE SHE WOULD BE RECEIVING ANOTHER IMPLANT. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620074 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00643169864191

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention