BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 8645800 · Received May 28, 2019

    Report

    Report Number
    3004209178-2019-10331
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Date of Event
    May 6, 2019
    Report Date
    July 2, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM PATIENT. THEY REPORTED CAUSE WAS NOT KNOWN. THEY STATED THAT IT WAS WORKING NOW. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT REGARDING THEIR IMPLANTABLE NEUROSTIMULATOR (INS) FOR FECAL INCONTINENCE AND GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT PATIENT WAS NOT GETTING THERAPY RELIEF. PATIENT STATED THAT BACK THEN AT 0.45 THEY COULD FEEL TINGLING BUT NOW EVEN AT 1.00V THEY DIDN'T FEEL ANYTHING. PATIENT STATES THEIR BOWEL HAS BEEN ACTING CRAZY AND FELT LIKE THEY CAN FEEL THE DEVICE WHEN THEY ATE. THEY MENTIONED THEY HAD AN MRI OF THEIR HEAD 6 MONTHS AGO AND DIDN'T KNOW IF THAT COULD AFFECT THE INS. DURING CALL, PATIENT HAD ACCESS TO THE PROGRAMMER. THEY SYNCHED AND SHOWED STIM WAS OFF. IT WAS REVIEWED TO TURNED THERAPY ON AS IT NEEDED TO BE ON FOR EFFECTIVENESS. HOWEVER, PATIENT STILL DIDN'T FEEL STIMULATION EVEN WHEN INCREASING STIMULATION FOR PROGRAM 1. IT WAS SUGGESTED PATIENT SWITCH TO PROGRAM 2 AND INCREASE STIMULATION HOWEVER THAT DID NOT RESOLVE THE ISSUE EITHER. PATIENT ADVISED TO FOLLOW UP WITH HEALTHCARE PROFESSIONAL (HCP) TO CHECK ON DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441505 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR