BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 10052669 · Received May 13, 2020

    Report

    Report Number
    3004209178-2020-08533
    Event Type
    Injury
    Date Received
    May 13, 2020
    Date of Event
    May 12, 2020
    Report Date
    May 13, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169864191
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389S-40, LOT#: V030207, IMPLANTED: (B)(6) 2018, EXPLANTED: (B)(6) 2020, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT#: V030207, IMPLANTED: (B)(6) 2018, EXPLANTED: (B)(6) 2020, PRODUCT TYPE: LEAD. PRODUCT ID: 3708660, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2018, EXPLANTED: (B)(6) 2020, PRODUCT TYPE: EXTENSION. PRODUCT ID :3708660, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2018, EXPLANTED: (B)(6) 2020, PRODUCT TYPE: EXTENSION. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3389S-40, SERIAL/LOT #: V030207, UBD: 19-JAN-2010, UDI#: (B)(4) ; PRODUCT ID: 3389S-40, SERIAL/LOT #: V030207, UBD: 19-JAN-2010, UDI#: (B)(4) ; PRODUCT ID: 3708660, SERIAL/LOT #: (B)(4), UBD: 21-MAR-2022, UDI#: (B)(4) ; PRODUCT ID: 3708660, SERIAL/LOT #: (B)(4), UBD: 21-MAR-2022, 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 HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE POCKET SITE, ALONG THE NECK NEAR THE EXTENSIONS, AND THE SKIN WAS ERODED NEAR THE STIMLOCS. THE PATIENT'S SYSTEM WAS REMOVED. THE ISSUE WAS RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517416 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00643169864191

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention