BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 11340831 · Received February 17, 2021

    Report

    Report Number
    2182207-2021-00276
    Event Type
    Injury
    Date Received
    February 17, 2021
    Report Date
    February 17, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD (EVENT 2), SERIAL#: UNKNOWN, IMPLANTED: (B)(6) 2018, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN, UBD: ASKU, UDI#: ASKU. PLEASE NOTE THE SPECIFIC DEVICE IMPLANT AND EXPLANT DATES ARE UNKNOWN AT THIS TIME; ONLY MONTHS AND YEARS WERE PROVIDED TO THE MANUFACTURER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE (B)(6) REGISTRY (NNR) IN THE (B)(6) REPORTED ANONYMIZED, AGGREGATE DATA INVOLVING HISTORICAL DEVICE ISSUES. THE REPORTED EVENTS WERE AS FOLLOWS: REPORTED EVENTS: 1. 1 PATIENT (B)(6) UNDERWENT A SYSTEM REVISION FOR AN UNKNOWN REASON. 2. 1 PATIENT (B)(6) UNDERWENT A SYSTEM REVISION DUE TO A LEAD FRACTURE. NO FURTHER EVENT INFORMATION WAS REPORTED; NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236305 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 97715

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention