BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2552207 · Received April 27, 2012

    Report

    Report Number
    3004209178-2012-02760
    Event Type
    Injury
    Date Received
    April 27, 2012
    Report Date
    April 5, 2012
    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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093-28 LOT# V855059, IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD.

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093-28 LOT# V855059, IMPLANTED: 2012 (B)(6), PRODUCT TYP LEAD, PRODUCT ID, 3037 SERIAL# (B)(4), PRODUCT TYP PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE CAUSE OF THE EVENT WAS DUE TO LACK OF EFFECT. IT WAS NOTED THAT PATIENT "PREFERRED A REMOVAL" OF THE DEVICE. IT WAS NOTED THAT AN X-RAY WAS PERFORMED ON (B)(6) 2012 AND REVEALED "GOOD LEAD PLACEMENT." IT WAS NOTED THAT THE LEAD AND IMPLANTABLE NEUROSTIMULATOR (INS) WERE EXPLANTED ON (B)(6) 2012. NO HOSPITALIZATION OF THE PATIENT WAS REQUIRED. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE PATIENT ATTEMPTED TO INCREASE THE STIMULATION, SHE INCREASED IT TO A POINT WHERE IT "SHOT INTO HER RIGHT SIDE." THE PATIENT'S PHYSICIAN COUNSELED HER TO TURN THE STIMULATION DOWN WHICH CORRECTED THE ISSUE. HOWEVER, THE PATIENT ALSO HAD A LOSS OF THERAPEUTIC EFFECT AND NO STIMULATION SENSATION. THE PATIENT EXPERIENCED A LOSS OF BLADDER CONTROL THAT STARTED 2-3 WEEKS AGO. THERE WAS NO KNOWN EVENT; THE PATIENT JUST LOST STIMULATION. THE PATIENT WANTED THE DEVICE REMOVED BECAUSE, IT WAS NOT WORKING AND SHE WAS FRUSTRATED. THE PATIENT HAD AN APPOINTMENT WITH HER HEALTH CARE PROFESSIONAL IN 1 MONTH AND UNTIL THEN SHE WAS GOING TO KEEP A DIARY OF HER SYMPTOMS WHILE USING DIFFERENT PROGRAMS ON THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention