BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 15385791 · Received September 8, 2022

    Report

    Report Number
    3004209178-2022-11544
    Event Type
    Injury
    Date Received
    September 8, 2022
    Report Date
    September 8, 2022
    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
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THEY WANT TO HAVE THE DEVICE REMOVED BECAUSE IT IS OF NO USE TO THEM. . PATIENT SAID THEY USED TO HAVE STIM AT 7.0 OR AS HIGH AS IT GOES. PATIENT SAID AT 2.0 THEY ARE GETTING SHOCKED BAD. PATIENT SAID ON 1.0 THEY CAN STILL FEEL THE PULSATING EVEN AFTER A WEEK. PATIENT SAID THE DEVICE US NOT HELPING THEIR SYMPTOMS AND THE HCP TOLD THEM TO TURN STIM OFF. PATIENT SAID THE INS BUGS THEM, PATIENT SAID THE INS "FLIPS AND FLOPS" IN THEIR BODY. PATIENT SAID THEY NO LONGER HAVE OAB ISSUES. PATIENT SAID THEY STILL HAVE WHAT THE HCP CALLS BLADDER SPASMS, BUT PATIENT SAID THEY FEEL MORE LIKE LABOR PAIN AND BRAXTON HICKS WHICH WOULD BE SPIRITUAL AT THIS POINT. AGENT DID NOT ASK ABOUT THE CIRCUMSTANCES THAT LED TO THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256412 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention