BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3226846 · Received July 15, 2013

    Report

    Report Number
    3004209178-2013-11743
    Event Type
    Injury
    Date Received
    July 15, 2013
    Report Date
    March 1, 2013
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4): PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID 3093-33, LOT# V871805, IMPLANTED: (B)(6) 2012: PRODUCT TYPE LEAD; PRODUCT ID 3093-33, LOT# V871805, IMPLANTED: (B)(6) 2012: PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED HE PATIENT ¿RECEIVED ASSISTANCE FROM THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED¿ ON 2013-(B)(6). IT WAS NOTED THE PATIENT WAS SCHEDULED FOR A ¿REMOVAL¿ ON 2013-(B)(6). IT WAS UNKNOWN WHICH COMPONENTS WERE SCHEDULED TO BE REMOVED AT THE TIME OF REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NO STIMULATION SENSATION. THE PATIENT NEVER HAD THERAPEUTIC EFFECT. IT WAS REPORTED THAT THE PATIENT ¿DEDUCED¿ DURING A REPROGRAMMING SESSION IN (B)(6) 2013 THAT ONLY ONE ELECTRODE WAS WORKING. IT WAS STATED THAT ELECTRODE IS NOW NOT WORKING. THE PATIENT PLANNED TO ADDRESS HER CONCERNS WITH HER PHYSICIAN. COMPATIBILITY GUIDELINES FOR SEVERAL MEDICAL DEVICES/PROCEDURES WAS ALSO REQUESTED. ADDITIONAL FOLLOW UP WAS REQUESTED. IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326853 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention