BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3007566237-2016-04584

    MDR report key: 6213290 · Received December 29, 2016

    Report

    Report Number
    3007566237-2016-04584
    Event Type
    Malfunction
    Date Received
    December 29, 2016
    Report Date
    December 29, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR REPORTED THAT HER HEALTHCARE PROVIDER MENTIONED THAT SOME PREVIOUS PATIENT'S INS SYSTEMS IMPACTED BY SCREENING DEVICES. THE STATUS OF THE PATIENTS IS UNKNOWN, NO ADDITIONAL INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT. NO PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863130 LNQ MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1