BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFY ENHANCED

    MDR report key: 10741017 · Received October 27, 2020

    Report

    Report Number
    2182207-2020-01150
    Event Type
    Injury
    Date Received
    October 27, 2020
    Date of Event
    October 23, 2020
    Report Date
    October 27, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URGE INCONTINENCE AND URGENCY FREQUENCY. IT WAS REPORTED THAT WORSENING SYMPTOMS. PATIENT STATED THAT ON MONDAY PRIOR TO HAVING THE PROCEDURE THEY HAD SYMPTOMS OF A BLADDER INFECTION. THE PATIENT WAS THEN UP 10 TIMES TO VOID DURING  SLEEP WITH STINGING WHEN VOIDING. THE PATIENT SAW PHYSICIAN ON THURSDAY AND WAS TESTED AND DOES HAVE AN INFECTION. THE PATIENT WAS ADVISED TO TAKE CIPRO AND TURN THE MACHINE OFF FOR 2 DAYS. THE PATIENT WILL HAVE THE DEVICE OFF UNTIL SATURDAY EVENING. THE PATIENT IS ONLY VOIDING LESS THAN AN OZ PER VOID AND IS IN PAIN.  PATIENT STATED THEY  LACK OF SLEEP  DUE TO GETTING UP FREQUENTLY TO VOID THE PATIENT WAS ADVISED TO TAKE AZO FOR THE BLADDER PAIN. THE PATIENT WILL TRY TURNING THE DEVICE ON SATURDAY NIGHT BUT IF VOIDS FREQUENTLY THEY  WILL BE TURNING IT BACK OFF.  NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED AT THIS TIME. "OMITTED  RULE OUT INFORMATION IN GENERAL ON UTI".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206810 VERIFY ENHANCED STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 353101

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention