BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2750678 · Received September 19, 2012

    Report

    Report Number
    3004209178-2012-08246
    Event Type
    Injury
    Date Received
    September 19, 2012
    Report Date
    November 12, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093-28 LOT# V945725 IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANTABLE NEUROSTIMULATOR (INS) WAS CLOSE TO THE SKIN SURFACE (WITHIN A COUPLE MM) AND WAS CAUSING PAIN. IT WAS REPORTED THAT SINCE THE IMPLANT, THE PATIENT HAD CLEAR DRAINAGE AND SCABBING WHERE THE LEADS WERE LOCATED. THE PATIENT ALSO HAD FEVERS ON AND OFF. THE PHYSICIAN SAID NOTHING WAS WRONG. IT WAS ALSO REPORTED THAT AFTER SURGERY, THE PATIENT'S ENTIRE LEFT BUTTOCK WAS CONTRACTING; HOWEVER, THIS WAS RESOLVED BY REDUCING THE STIMULATION. IN (B)(6), THE PATIENT HAD A FALL THAT WAS NOTED AS THE ORIGIN OF THE INS PROBLEM, BUT THE IMPLANT WAS ALREADY AT AN ANGLE EVEN BEFORE THE FALL. THE PATIENT ALSO FELL A WEEK PRIOR TO (B)(6) 2012 WHEN SHE FAINTED. IT WAS NOTED THAT THE PATIENT CAN FEEL THE IMPLANT MOVING. THERE WERE NO RETURN OF SYMPTOMS AND THERAPY WAS WORKING AS OF (B)(6) 2012. IT WAS LATER REPORTED THAT THE PATIENT LOST THERAPEUTIC EFFECT. A LOSS IN THERAPY OCCURRED A COUPLE DAYS PRIOR TO (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT'S SYMPTOMS RETURNED. IN ADDITION, THE PATIENT EXPERIENCED AN INCREASE IN BOWEL MOVEMENT. IT WAS THOUGHT, THE STIMULATION MIGHT NOW BE AFFECTING THE RECTUM AREA. IT WAS ALSO REPORTED THAT THE DEVICE WAS ABOUT TO POKE THROUGH THE SKIN. THE PATIENT HAD AN APPOINTMENT WITH A HEALTH CARE PROFESSIONAL ON (B)(6) 2012.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT FELL ((B)(6) 2012) AND HER IMPLANT MOVED. THE WOUND WAS SAID TO HAVE DEHISCED AND THE WOUND WOULD NOT HEAL TO A SIZE SMALLER THAN A Q-TIP. THE PATIENT DID WOUND CARE FOR 3-4 MONTHS BEFORE THE IMPLANT WAS REMOVED (B)(6) 2012. THE PATIENT'S HEALTHCARE PROVIDER (HCP) TOLD THE PATIENT THAT THE IMPLANT HAD TO COME OUT. THE FALL WAS SAID TO HAVE HAPPENED DUE TO THE PATIENT BREAKING HER LEG TWICE. THE PATIENT NOW WORE A SPLINT AND DID NOT FALL AT ALL.

    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 00058 YR Required Intervention