BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 7112510 · Received December 13, 2017

    Report

    Report Number
    3004209178-2017-25891
    Event Type
    Injury
    Date Received
    December 13, 2017
    Date of Event
    October 12, 2017
    Report Date
    December 14, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    UDI-DI
    00613994287731
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3093-41, LOT# V192504, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2017, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    FOLLOW-UP WITH THE MANUFACTURER REPRESENTATIVE (REP) DETERMINED THAT THE BATTERY DEPLETION WAS NORMAL BATTERY DEPLETION OF THE INS AND THE CAUSE OF THE PATIENT FEELING STIMULATION DOWN THEIR LEG WAS NOT DETERMINED. PATIENT STATUS IS UNKNOWN AT THE TIME OF THIS REPORT. THERE WERE NO FURTHER COMPLICATION REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IM PLANTABLE NEURO STIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE PATIENT'S SYMPTOMS WERE NOT AS CONTROLLED, STARTING APPROXIMATELY TWO MONTHS AGO. PATIENT STATED THAT THEY COULD FEEL STIMULATION DOWN THEIR LEG FROM TIME TO TIME AND THE SENSATION WAS NO LONGER VAGINAL. NO ENVIRONMENTAL OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE WERE REPORTED. IT WAS NOTED THAT THE DOCTOR ATTEMPTED REPROGRAMMING IN THE CLINIC AT SOME POINT WITHIN THE PAST TWO MONTHS. BOTH THE LEAD AND THE INS WHICH WAS AT END OF SERVICE (EOS) WERE SURGICALLY REPLACED AND THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED/ ANTICIPATED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894452 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023 00613994287731

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention