BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3082560 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-07009
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    May 30, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# VA013QD, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION TO HER POCKET SITE AS ¿THERE WERE SO MANY MISTAKES THE FIRST TIME.¿ IT WAS NOTED THAT ¿SCAR TISSUE BUILT UP¿ AND ¿CAUSED THE POCKET NOT TO BE DEEP.¿ SINCE THE REVISION, THE PATIENT HAD BEEN VERY HAPPY WITH THE THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION TO HER POCKET SITE AS "THERE WERE SO MANY MISTAKES THE FIRST TIME". IT WAS NOTED THAT "SCAR TISSUE BUILT UP" AND "CAUSED THE POCKET NOT TO BE DEEP". SINCE THE REVISION, THE PATIENT HAD BEEN VERY HAPPY WITH THE THERAPY. SEE MANUFACTURER REPORT NO. 3004209178-2013-07006 WITH RESPECT TO PATIENT'S PREVIOUS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185413 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention