BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFY ENHANCED

    MDR report key: 12990523 · Received December 13, 2021

    Report

    Report Number
    3007566237-2021-00106
    Event Type
    Malfunction
    Date Received
    December 13, 2021
    Date of Event
    December 9, 2021
    Report Date
    December 13, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCT: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT#: UNKNOWN, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR NON-OBSTRUCTIVE URINARY RETENTION. THE ADVANCED EVALUATION BEGAN ON (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT HAD A LEAD DISLODGE. ADDITIONAL INFORMATION WAS RECEIVED AND THE PATIENT STATED THEY HAD AN EGT STUDY DONE ON THE 9TH AND THE LEAD CAME UNATTACHED. THERE WERE NO  PATIENT COMPLICATIONS REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1881058 VERIFY ENHANCED STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC NEUROMODULATION 353101 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male