BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 7302826 · Received February 28, 2018

    Report

    Report Number
    3004209178-2018-04150
    Event Type
    Malfunction
    Date Received
    February 28, 2018
    Date of Event
    February 8, 2018
    Report Date
    June 4, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER. IT WAS REPORTED THE PATIENT STATED THEIR THERAPY WAS NOT WORKING. THE PATIENT RE-ITERATED THE FIRST 2 NIGHTS WERE WONDERFUL BUT AFTER THAT THEY HAD NOT GOTTEN SYMPTOM CONTROL. THE PATIENT STATED THEY STARTED OFF ON P4 AND A COUPLE OF WEEKS AGO THE HEALTH CARE PHYSICIAN CHANGED THEM TO P1 AT 2.6. THERE WERE NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AND IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT HE PATIENT ONLY HAD 1-2 DAYS WHERE THE IMPLANT WAS HELPING AND THEY WERE ABLE TO SLEEP THROUGH THE NIGHT. PATIENT STATED NOW THEY COULDN'T MAKE IT TO THE BATHROOM AND WAS WAKING UP EVERY HOUR. PATIENT SAW THE HEALTHCARE PROVIDER AND THEY DID MORE ADJUSTMENTS, THEY REPORTED THEY MIGHT HAVE ONE GOOD NIGHT, BUT THEN WENT BACK TO HAVING ISSUES. PATIENT STARTED ON PROGRAM 1 AND WAS TOLD BY THEIR HEALTHCARE PROVIDER IT WAS SET TO 1.5V, BUT IT SHOWED 1.0V AND WAS NOW ON PROGRAM 4. PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO DISCUSS SYMPTOMS AND SETTINGS. THE PATIENT ALSO REPORTED THEY WERE EDUCATED UNDER ANESTHESIA. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL: THE PATIENT'S IPG WAS FOUND TO BE TURNED OFF, AND THE HCP TURNED IT BACK ON. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145596 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR