BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3902358 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-12267
    Event Type
    Injury
    Date Received
    June 30, 2014
    Report Date
    June 9, 2014
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# VA0ETPU, IMPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE LEAD WAS PLACED IN S3 ON (B)(6) 2014 (MANUFACTURER¿S DEVICE REGISTRY INDICATES A NEW LEAD WAS PLACED) AND THAT THERE WAS ¿GREAT RESPONSE¿. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOR THE PAST 2.5 WEEKS THE PATIENT HAD HAD PAIN IN THEIR HIP RUNNING DOWN INTO THEIR LEG AND WAS IN THE UPPER PART OF THEIR LEG. THE PATIENT TURNED THEIR STIMULATION DOWN A LITTLE BIT WHICH HELPED SOME BUT WHEN THEY DID THIS THEY DIDN¿T GET SYMPTOM RELIEF. IT WAS NOTED THAT THE PATIENT TURNED IT OFF ONE TIME 2 NIGHTS AGO JUST TO SEE IF THAT WOULD HELP AND IT HELPED THE PAIN BUT THEY NEEDED IT ON TO GET RELIEF. THE PATIENT¿S HEALTH CARE PROVIDER (HCP) AND THEIR PHYSICIAN¿S ASSISTANT (PA) WERE OUT FOR A WEEK AND ASKED IF A MANUFACTURER REPRESENTATIVE COULD BE REACHED FOR THE PATIENT. IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE CALLED THE PATIENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS TURNING IT OFF UNTIL 2014 (B)(6) AND WOULD BE SEEING THEIR HCP NEXT WEEK. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S LEAD HAD MOVED AND THEY WERE GOING TO HAVE A LEAD REVISION ON 2014 (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379475 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention