BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFY ENHANCED

    MDR report key: 11592298 · Received March 30, 2021

    Report

    Report Number
    2182207-2021-00554
    Event Type
    Malfunction
    Date Received
    March 30, 2021
    Date of Event
    March 3, 2021
    Report Date
    March 30, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 306001 LOT# 60259779 SERIAL# UNKNOWN. PRODUCT TYPE: SCREENING DEVICE. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 306001, SERIAL/LOT #: (B)(4), UBD: 22-SEP-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 PROVIDER REGARDING A TRIAL PATIENT WHO WAS USING A EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PNE LEAD INCLUDED IN THE PNE KIT AND A SECOND LEAD GOT CAUGHT ON THE NEEDLE WHILE TRYING TO DEPLOY. AS A RESULT THE HUB OF THE NEEDLE PULLED THE PNE LEAD OUT OF PLACE AND STRETCHED THE PNE LEAD OUT OF SHAPE. THEY USED A DIFFERENT NEEDLE AND NEW LEADS AND WERE ABLE TO PLACE BOTH SIDES FOR THE PNE. PATIENT IS CURRENTLY IN AN EVALUATION. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487740 VERIFY ENHANCED STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 353101

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR