BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 8275360 · Received January 24, 2019

    Report

    Report Number
    3004209178-2019-01666
    Event Type
    Injury
    Date Received
    January 24, 2019
    Date of Event
    November 1, 2018
    Report Date
    March 21, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE PMA WAS CORRECTED TO P080025. 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.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. WHEN ASKED THE CIRCUMSTANCES THAT LED TO THE LEAKING AND IMPLANT REPOSITIONED THE PATIENT RESPONDED IT WAS PRESSING ON THEIR SCIATIC NERVE. WHEN ASKED THE STEPS TAKEN TO RESOLVE THE LEAKING WAS REPOSITIONING OF THE IMPLANT THE PATIENT RESPONDED IT WAS PINCHING THEIR SCIATIC NERVE. THERE WERE NO FURTHER SYMPTOMS OR COMPLICATIONS REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT REGARDING THEIR IMPLANTABLE NEUROSTIMULATOR (INS) FOR FECAL INCONTINENCE/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. THE PATIENT REPORTED THAT HE WAS HAVING LEAKAGE. THE HEALTHCARE PROVIDER REPOSITIONED INS FROM RIGHT SIDE TO LEFT SIDE OF THE BODY. THE PATIENT WAS ABLE TO ACCESS THE PATIENT PROGRAMMER AND SYNCED WITH INS. IT WAS NOTED THAT STIMULATION WAS ON AND PROGRAM 4 AT 3.6 V. PATIENT INCREASE STIM TO 4.4V AND PATIENT WAS FEELING STIMULATION IN THE CORRECT AREA. THERE WERE NO FURTHER SYMPTOMS OR COMPLICATIONS REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66579 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention