BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2972068 · Received February 21, 2013

    Report

    Report Number
    3007566237-2013-00559
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    February 15, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT'S LEAD AND STIMULATOR WERE IMPLANTED IN (B)(6) 2011 AND THE PATIENT FIRST MET WITH A REP REPRESENTATIVE OR HEALTHCARE PROVIDER IN THE UNITED STATES ON (B)(6) 2012. IT WAS REPORTED THE PATIENT FELT STIMULATION DOWN HER RIGHT LEG AND IT WAS UNCOMFORTABLE AND NOT CONTROLLING HER SYMPTOMS. IT WAS REPORTED THE PATIENT'S X-RAY THAT SHOWED THE LEAD WAS IN S4 WAS TAKEN ON (B)(6) 2013. IT WAS ALSO REPORTED THE MANUFACTURER REPRESENTATIVE SET A NEW PROGRAM FOR THE PATIENT THAT SAME DAY BUT THE PATIENT RECEIVED NO IMPROVEMENT. THE PROGRAM WAS ONLY ABLE TO BE ADJUSTED ONE TIME BECAUSE THE PATIENT DID NOT RECEIVE A PATIENT CONTROLLER WHEN IMPLANTED IN MEXICO. THE LEAD AND STIMULATOR WERE REMOVED AND A SMALLER STIMULATOR WAS IMPLANTED ALONG WITH A NEW LEAD WHICH WAS PLACED IN S3. IT WAS REPORTED THE PATIENT WAS "DOING MUCH BETTER," FEELING THE STIMULATION COMFORTABLY, AND HER SYMPTOMS HAD IMPROVED GREATER THAN 50 PERCENT.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT EXPERIENCED NEVER HAVING THERAPEUTIC EFFECT (AND ACTUALLY MADE THEM WORSE) FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT THE PATIENT WAS IMPLANT WITH THE DEVICE IN MEXICO AND TRAVELED TO THE US TO HAVE THE DEVICE CHECKED. IT WAS ALSO REPORTED THAT THE PATIENT HAD NEVER BEEN GIVEN A PATIENT PROGRAMMER COMPONENT. FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD AN X-RAY WHICH SHOWED THE LEAD WAS LOCATED AT S4. A SURGICAL REVISION WAS THEN PERFORMED WHERE THE INS AND LEAD WERE EXPLANTED AND THE PATIENT RE-IMPLANTED WITH A NEW INS AND A BETTER POSITIONED LEAD. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75654 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention