BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM X

    MDR report key: 20769697 · Received November 25, 2024

    Report

    Report Number
    3004209178-2024-22556
    Event Type
    Injury
    Date Received
    November 25, 2024
    Date of Event
    October 3, 2024
    Report Date
    November 25, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 URGE INCONTINENCE AND URINARY/BOWEL DYSFUNCTION. IT WAS REPORTED THAT THEY HAD COME TO REALIZE THAT THE DEVICE WAS IN A COMPLETELY WRONG PLACE, VERY LOW IN THEIR BUTTOCK, LITERALLY POKING IN THE SIDE OF THEIR CRACK, WHEN THEY SIT DOWN ON THE DEVICE IT WOULD POKE THROUGH AND THE WOUND POPPED OPEN AND HAD BEEN OPEN SINCE SURGERY ON (B)(6). PATIENT (PT) SAID THEY WERE SUPPOSED TO HAVE A ONE WEEK POST OP APPOINTMENT BUT IT THE NURSE NEVER SCHEDULED IT. PT SAID THEY HAD TO LAY ON EITHER THEIR LEFT OR RIGHT SIDE OR ON THEIR STOMACH BECAUSE WHEN THEY LAY ON THEIR BACK IT FEELS LIKE THEIR SKIN WAS BURNING, RIPPING, IT FELT CRAZY WHEN THEY LAY ON THEIR BUTT. PATIENT SAID AROUND THE (B)(6), THEY WOKE UP AND THE INS SITE FELT WET, THEY BANDAGED IT UP, FELL ASLEEP AND WHEN THEY WOKE UP, THEY HAD BLOOD ALL OVER THEIR COUCH, ALL OVER THEM, EVERYTHING WAS SATURATED. PATIENT WENT TO URGENT CARE WHERE THEY DID WOUND CARE, IT WASN'T INFECTED BUT IT WAS SWOLLEN AND RED, THEY WERE PUT ON ANOTHER ROUND OF ANTIBIOTICS AND FOLLOWED UP WITH THE SURGEON AND WHEN THE DOCTOR LOOKED AT IT THEY SAID: "HMM, I NEVER MAKE THAT MISTAKE AND (B)(6) DRAPED YOU FOR SURGERY." PT SAID THEY DON'T' KNOW WHAT THE DOCTOR MEANT BY THAT BUT THE DEVICE WAS NOT IN THE CORRECT PLACE AND THEY WILL HAVE A SURGERY TO REVISE THE DEVICE ON THURSDAY. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2235358 INTERSTIM X STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 97800 00763000484668

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention