BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM X

    MDR report key: 19339608 · Received May 17, 2024

    Report

    Report Number
    3004209178-2024-11170
    Event Type
    Malfunction
    Date Received
    May 17, 2024
    Date of Event
    April 1, 2024
    Report Date
    May 17, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00763000484668
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE IS APPROXIMATE. MONTH AND YEAR ARE CONFIRMED VALID. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DYSFUNCTION AND URGE INCONTINENCE. IT WAS REPORTED THAT THE PATIENT HAD CALLED INITIALLY BECAUSE THEY ALLEGED THE COMMUNICATOR WAS "NOT CHARGED" AND THAT THE "CONNECTION IS NOT FOUND." PATIENT SERVICES REVIEWED COMMUNICATOR FUNCTION AND BATTERY LIGHT CONSIDERATIONS WITH THE PATIENT AND THE PATIENT TURNED ON THE COMMUNICATOR, CONFIRMING IT WAS NOT PLUGGED IN. PATIENT STATED THEY SAW THE BLUE LIGHT FLASHING AND THE WHITE LIGHT AND NO BATTERY LIGHT WAS LIT UP. PATIENT SERVICES REVIEWED MEANING OF THIS AND HAD THE PATIENT ENTER INTO THE INTERSTIM X MYTHERAPY APPLICATION. PATIENT STATED "OH, I HAD BEEN GOING INTO THE "WHITE" APPLICATION PREVIOUSLY." COMMUNICATOR THEN PAIRED TO THE HANDSET AND THE PATIENT STATED "OH. I CAN TELL IT CONNECTED BECAUSE I CAN FEEL IT IN MY LEG." PATIENT CONFIRMED SHE HADN'T YET PLACED THE COMMUNICATOR OVER THE INS SITE YET BUT BY "FELT IT" PATIENT MEANT THEY FELT THE STIMULATION IN THEIR LEG UPON PAIRING THE COMMUNICATOR AND HANDSET. PATIENT STATED THEY THOUGHT THEY NEEDED TO TAKE THEIR STIMULATION LOWER, BECAUSE THEY WERE HAVING PROBLEMS WITH THEIR HIP AND THEY WERE FEELING THE STIMULATION IN THEIR LEG. PATIENT FURTHER CLARIFIED THAT THE HIP WAS SORE, WHICH WAS NEW FOR THEM. PATIENT STATED IT DIDN'T START FOR THEM UNTIL RIGHT AFTER THEY WERE IMPLANTED. PATIENT SERVICES ASKED THE PATIENT IF THE SORENESS FELT LIKE IT WAS FROM THE STIMULATION AND THE PATIENT STATED "IT MIGHT BE, YEAH." PATIENT STATED THEY HAD GOTTEN ANOTHER URINARY TRACT INFECTION AGAIN, THAT THEY'D JUST HAD ONE AND HAD GOTTEN THROUGH WITH TAKING THE MEDICATIONS FOR THAT ONE AND THEN THEY GOT ANOTHER ONE WHERE THEY HAD TO TAKE MORE ANTIBIOTICS. PATIENT STATED THEY KEPT THINKING THINGS WOULD GET BETTER FOR THEM BUT IT DIDN'T SO THEY SPOKE WITH MANUFACTURER REPRESENTATIVE (REP) ON (B)(6) 2024 ABOUT THE ISSUE AND THE REP HAD THE PATIENT INCREASE THEIR STIMULATION ON THEIR SAME PROGRAM AND INCREASING THE STIMULATION WAS WHEN THEY STARTED TO FEEL IT IN THE LEG. PATIENT SERVICES ASKED THE PATIENT IF THE REP HAD KNOWN THAT AND THE PATIENT STATED "I DON'T THINK HE HEARD ME." PATIENT STATED IT FELT LIKE THEIR SYMPTOMS WERE BETTER AGAIN AFTER THEY TOOK THEIR ANTIBIOTIC PILL LAST NIGHT. PATIENT SERVICES REVIEWED THERAPY EXPECTATIONS AS WELL AS PROGRAMMING AND STIMULATION CONSIDERATIONS WITH THE PATIENT AND THE PATIENT STATED THEY DIDN'T THINK THEY'D EVER FELT THE STIMULATION IN THEIR BIKE-SEAT REGION, THAT THEY HAD ALWAYS FELT IT IN THEIR LEG. PATIENT SERVICES REVIEWED THE POTENTIAL FOR SWITCHING TO A NEW PROGRAM AND PATIENT OPTED TO GO FROM PROGRAM 5 TO PROGRAM 4 HOWEVER WHEN THE PATIENT INCREASED THE STIMULATION ON PROGRAM 4 THEY STARTED FEELING IT AT THE INCISION SITE (WHICH PATIENT CONFIRMED WHEN CONNECTING THE INS WAS RIGHT UNDER THEIR INCISION). PATIENT SERVICES REVIEWED AGAIN THAT THE STIMULATION SHOULD ONLY BE FELT IN THE BIKE-SEAT SO THE PATIENT OPTED TO SWITCH TO PROGRAM 6 HOWEVER WHEN THEY WENT TO SWITCH TO PROGRAM 6, THEY GOT AN "OPERATION FAILED" MESSAGE AND HAD TO RETRY. THE PATIENT WAS THEN ABLE TO SWITCH TO PROGRAM 6 AND INCREASE THE STIMULATION TO 1.0 MA WHERE THEY FELT IT IN THEIR BUTTOCK. PATIENT STATED IT WASN'T IN THEIR LEG "AT LEAST" AND THAT THEY COULD SAY IT WAS PROBABLY AROUND THE AREA WHERE THE BIKE-SEAT WAS, THAT "IT COULD BE THE BIKE SEAT WHERE I'M FEELING IT NOW." PATIENT STATED THEY WOULD LEAVE THEIR SETTING LIKE THIS FOR A FEW DAYS AND MONITOR THEIR SYMPTOMS. PATIENT SERVICES REDIRECTED THE PATIENT TO FOLLOW UP WITH THEIR HEALTH CARE PROVIDER (HCP) ABOUT THEIR SYMPTOM CONCERNS AND TO DISCUSS PROGRAMMING CONSIDERATIONS. PATIENT STATED THEY WOULD REACH OUT TO THEIR HCP TO SET UP AN APPOINTMENT. DOCUMENTED REPORTED EVENT. NO FURTHER ACTION WAS TAKEN BY PATIENT SERVICES. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED PATIENT MENTIONED WHEN THEY WERE TRYING TO FIND THEIR INS SITE TO CONNECT, ABOUT THE PLACEMENT OF THEIR IMPLANTED SYSTEM, THAT "THEY HAD TO PUT IT AWAY FROM MY SPINE" (WHEN THEY DID THE IMPLANT) BECAUSE THE PATIENT HAD HAD BACK SURGERY IN THE PAST AND HAD A LOT OF SCAR TISSUE FROM THAT SURGERY. AT THE TIME PATIENT WASN'T RIGHT OVER INS HOWEVER THEY WERE ABLE TO LOCATE THE INS UNDER THE INCISION AND PATIENT WAS ABLE TO SUCCESSFULLY CONNECT TO THEIR THERAPY SETTINGS. EXTERNAL DEVICES WERE FUNCTIONING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744190 INTERSTIM X STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 97800 00763000484668

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female