BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 7925249 · Received October 2, 2018

    Report

    Report Number
    3004209178-2018-22000
    Event Type
    Injury
    Date Received
    October 2, 2018
    Date of Event
    September 11, 2018
    Report Date
    October 15, 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
    TX, 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. IT WAS REPORTED THAT THE PATIENT PROGRAMMER WAS ACCIDENTLY DROPPED INTO THE TOILET BASIN AND SUBMERGED BY A NURSE THAT WAS ASSISTING THE PATIENT TO THE RESTROOM ON (B)(6), 2018 FOLLOWING A SURGICAL PROCEDURE THAT THE PATIENT WAS IN THE RECOVERY ROOM FOR AT THE TIME. THE PATIENT NOTED THAT THE POOR COMMUNICATION WAS NOT RESOLVED AT THIS TIME, HOWEVER, THEY WERE NOT SURE IF IT WAS DUE TO THE FACT THAT SHE WAS STILL EXPERIENCING SOME SWELLING DUE TO THE SURGICAL PROCEDURE. THERE WERE NO FURTHER SYMPTOMS OR COMPLICATIONS REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR WHO REPORTED THAT THE PATIENT WAS ENCOUNTERING POOR COMMUNICATION BOTH WITH AND WITHOUT THE EXTERNAL PATIENT PROGRAMMER (PP) ANTENNA. DURING THE CALL THE PATIENT WAS ABLE TO COMMUNICATE WITH AND WITHOUT THE ANTENNA, BUT STILL DID ENCOUNTER POOR COMMUNICATION. THE PATIENT THEN INDICATED THAT THEY HAVE A GARMENT OVER THE IMPLANT AREA BECAUSE THEY HAD LIPOSUCTION SURGERY IN THAT AREA THE DAY PRIOR AND THERE WAS ALSO SWELLING. THE PATIENT WAS ADVISED HOW BANDAGES AND SWELLING CAN AFFECT COMMUNICATION AND WAS ADVISED TO ATTEMPT COMMUNICATION AFTER SWELLING IS REDUCED OR BANDAGE HAS BEEN REMOVED. THE SWELLING REPORTED WAS NOT RELATED TO THE DEVICE OR THERAPY. THE PATIENT CALLED AND SAID THEY WANTED TO WAIT BEFORE THEY CALLED BACK DUE TO UNRELATED SWELLING. PATIENT REPORTED THEY DECIDED TO USE THEIR CATHETER THE NIGHT PRIOR BECAUSE THEY DIDN'T THINK THEY WERE COMPLETELY EMPTYING THEIR BLADDER, THEY HAD A CHANGE IN URINE FLOW. PATIENT REPORTED THEY COULDN'T REMEMBER AND THOUGHT THE NURSE HAD SAID THEIR PATIENT PROGRAMMER HAD BEEN DROPPED IN THE TOILET, HOWEVER IT WAS POWERING UP FINE. DURING THE CALL, THE PATIENT REPORTED THEY SHOOK THE PATIENT PROGRAMMER AND COULD HEAR SOMETHING LOOSE. TROUBLESHOOTING WAS PERFORMED WITH AND WITHOUT THE ANTENNA DURING THE CALL AND THE PATIENT WAS RECEIVING THE POOR COMMUNICATION SCREEN. PATIENT'S HUSBAND STATED THE SWELLING HAD GONE DOWN. THE PATIENT WAS SENT A NEW PATIENT PROGRAMMER TO RESOLVE THE ISSUE. NO COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766426 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention