BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4811999 · Received June 2, 2015

    Report

    Report Number
    3004209178-2015-10093
    Event Type
    Injury
    Date Received
    June 2, 2015
    Report Date
    May 11, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 3889-28, LOT # VA0GN8U, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERAPY WORKED FINE FOR THE PATIENT THE FIRST MONTH OR TWO AFTER IMPLANT IN 2014 BUT THEN SHE BEGAN LEAKING MORE AND MORE. A REVISION SURGERY WAS DONE 5 WEEKS PRIOR TO THE REPORT AND, FOR THE FIRST TWO WEEKS, THE PATIENT HARDLY HAD ANY ACCIDENTS. SHE THEN STARTED TO LEAK AGAIN AND THE HEALTH CARE PROFESSIONAL (HCP) HAD EXHAUSTED PROGRAMMING BEFORE IMPLANTING A NEW LEAD WIRE. THE PATIENT WAS TO SEE THE HCP AGAIN IN TWO WEEKS. THE PATIENT ALSO STATED THAT SHE HAD BEEN VERY CAREFUL NOT TO BEND OVER OR DO ANYTHING TO CAUSE A LEAD ISSUE. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355980 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention