BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXONICS

    MDR report key: 10059746 · Received May 14, 2020

    Report

    Report Number
    3002968685-2020-00040
    Event Type
    Malfunction
    Date Received
    May 14, 2020
    Date of Event
    April 17, 2020
    Report Date
    July 22, 2020
    Manufacturer
    AXONICS MODULATION TECHNOLOGIES, INC.
    Product Code
    EZW
    UDI-DI
    10810005340141
    PMA / PMN Number
    P180046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A CORRECTION TO THE MEDWATCH FORM SUBMITTED ON 05/14/2020 FOR 3002968685-2020-00040. CORRECTING SECTION D4 - MODEL NUMBER, EXPIRATION DATE, SERIAL NUMBER AND UDI NUMBER FIELDS. THE MAIN DEVICE INVOLVED IS THE IPG (NEUROSTIMULATOR), MODEL 1101. THE CONCOMITANT PRODUCT IS THE TINED LEAD, MODEL 1201. SECTION D11 HAS BEEN UPDATED AS A RESULT.

    Description of Event or Problem · 0

    SEE MEDWATCH FORM 3002968685-2020-00040 SUBMITTED ON 05/14/2020.

    Description of Event or Problem · 1

    AXONICS WAS MADE AWARE ON (B)(6) 2020 THAT A PATIENT HAD NOT BEEN FEELING STIMULATION FOR NEARLY A MONTH AND SYMPTOMS WERE RETURNING. THEY REPORTED THAT THEY HAVE INCREASED STIMULATION FOR OVER A WEEK WITH NO CHANGES. DURING THE CALL TO REPORT ON THEIR SITUATION, THE PATIENT RAISE THE STIMULATION LEVEL, BUT DID NOT FEELING ANYTHING. THE PATIENT WAS ABLE TO REACH THEIR REPRESENTATIVE AND DISCUSS THE SITUATION WITH THEM. THE REPRESENTATIVE INDICATED THE PATIENT WILL NEED TO BE REPROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521479 AXONICS NEUROSTIMULATOR EZW AXONICS MODULATION TECHNOLOGIES, INC. 1101 10810005340141

    Patients

    Seq Age Sex Outcome Treatment
    1 TINED LEAD KIT, MODEL 1201