BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 11624427 · Received April 6, 2021

    Report

    Report Number
    3004209178-2021-05556
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    December 21, 2012
    Report Date
    April 6, 2021
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-33, LOT# V963187, PRODUCT TYPE LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3093-33, SERIAL/LOT #: (B)(4), UBD: 09-MAR-2016. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT THE PATIENT STATED EVER SINCE THEY HAD THE DEVICE PUT IT, IT'S CAUSED THEM MASSIVE LYMPHATIC ISSUES. THE PATIENT STATED AS SOON AS THEY GO THE DEVICE IMPLANTED THEY WERE SO IMPACTED THEY COULDN'T FILL THE DEVICE. THE PATIENT REPORTS BEING HARD AS A ROCK. THE PATIENT STATED THE LEAD WIRE IS CAUSING PROBLEMS AND HAS A LOOP WHICH THEY CAN FEEL. THE PATIENT STATED THEY SHOULD'VE NEVER GOTTEN THE DEVICE BECAUSE THEY NEVER NEEDED IT IN THE FIRST PLACE. THE PATIENT STATED THE PROBLEM HAS BEEN TAKEN CARE OF AND HAD NOTHING TO DO WITH THE DEVICE OR THERAPY. THE PATIENT STATED THEY HAVE HAD THE DEVICE TURNED OFF SINCE 3 MONTHS AFTER THE DEVICE WAS IMPLANTED. THE PATIENT WANTS THE DEVICE REMOVED SINCE IT'S BEEN 10 YEARS AND IT'S CAUSING ISSUES. THE PATIENT DID NOT HAVE THEIR PROGRAMMER WITH THEM SO THEY WERE UNABLE TO DETERMINE IMPLANT STATUS ON THE CALL. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522549 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR