BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 9865241 · Received March 23, 2020

    Report

    Report Number
    2182207-2020-00046
    Event Type
    Injury
    Date Received
    March 23, 2020
    Report Date
    March 23, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_RECHARGER_ACC, LOT# UNKNOWN, PRODUCT TYPE: RECHARGER. PRODUCT ID: NEU_UNKNOWN, LOT# UNKNOWN, PRODUCT TYPE: UNKNOWN. PRODUCT ID: NEU_UNKNOWN_PROG, LOT# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. PRODUCT ID NEU_ENS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE EXTERNAL NEUROSTIMULATOR. PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD. PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Description of Event or Problem · 1

    CONCERNS EVOLVE WORKFLOW AT THE PAIN CLINIC AT THE (B)(6) HOSPITAL SUMMARY: AT THE PAIN CLINIC AT THE (B)(6) HOSPITAL, BETWEEN ARPIL 2018 ¿ DECEMBER 2019, 38 PATIENTS WERE IMPLANTED WITH A COMPLETE MEDTRONIC SCS SYSTEM (VECTRIS LEAD 75 DIRECTLY CONNECTED TO AN INTELLIS ADAPTIVE STIM IPG). PATIENTS WERE INCLUDED ACCORDING TO THE GUIDELINES OF THE DUTCH NEUROMODULATION SOCIETY (VERENIGING VOOR NEUROMODULATIE NEDERLAND (VVNN), IN COMBINATION WITH THE QUESTIONNAIRES OF THE PROMISE DATABASE. REPORTED EVENT: ONE PATIENT HAD AN INFECTION, AFTER WHICH THE SYSTEM WAS REMOVED. NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331657 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention