BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3685359 · Received March 18, 2014

    Report

    Report Number
    3004209178-2014-04576
    Event Type
    Injury
    Date Received
    March 18, 2014
    Date of Event
    February 20, 2012
    Report Date
    February 20, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# V840299, IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S ORIGINAL IMPLANT WAS REMOVED ABOUT TWO YEARS AGO BECAUSE, PATIENT HAD LOST A LOT OF WEIGHT AND STIMULATOR WAS FLOATING AROUND HITTING BONE AND IRRITATING PATIENT. THE PATIENT HAD TO SEE A PAIN SPECIALIST BECAUSE OF THE PAIN AND PATIENT¿S INTERSTIM HEALTHCARE PROVIDER RECOMMENDED PATIENT HAVE DEVICE TAKEN OUT. THE HEALTHCARE PROVIDER TRIED TO RELIEVE PATIENT BLADDER SYMPTOMS WITH ORAL MEDICATION BUT THAT DIDN'T WORK. THE HEALTHCARE PROVIDER SUGGESTED TRYING THE INTERSTIM IMPLANT AGAIN. PATIENT WAS IMPLANTED TODAY WITH THEIR 2ND INTERSTIM DEVICE. THE PATIENT WANTED HELP INCREASING HIS STIMULATION. THE PATIENT WAS ABLE TO INCREASE DURING CALL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY. IT WAS NOTED THAT THE PATIENT HAD A SCHEDULE APPOINTMENT FOR (B)(6). IT WAS UNCLEAR IF THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT THE PATIENT WAS WORKING WITH THEIR HEALTHCARE PROVIDER OR MANUFACTURER REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161731 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Required Intervention