BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2771743 · Received October 4, 2012

    Report

    Report Number
    3004209178-2012-08869
    Event Type
    Injury
    Date Received
    October 4, 2012
    Date of Event
    June 3, 2011
    Report Date
    September 10, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V573248, IMPLANTED: 2010 (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 SUPERFICIAL BATTERY PLACEMENT WAS CAUSING IRRITATION. THE DEVICE PLACEMENT STARTED HURTING IN (B)(6) 2012. THE BATTERY PLACEMENT WAS VERY SORE; "IT'S SUPERFICIAL AND POSITIONED CORRECTLY." PATIENT HAD HARD TIME SLEEPING AND PATIENT COULD NOT LIE ON HER BACK. THE DEVICE WORKED FINE, BUT THE POSITION WAS IRRITATING AND PATIENT WOULD LIKE IT MOVED. THERE WAS NO REDNESS AT THE SITE. PATIENT WAS STILL EXPERIENCING PAIN AND OTHER SYMPTOMS ON (B)(6) 2012 AND (B)(6) 2012. THE SYMPTOMS OCCURRED AT NEUROSTIMULATOR POCKET INCISION SITE. THE LEAD WAS EXPLANTED ON (B)(6) 2012 AND THE NEUROSTIMULATOR WAS REVISED ON (B)(6) 2011. COMPUTATION TOMOGRAPHY AND URINALYSIS WERE PERFORMED. RESULTS OF BOTH TESTS WERE WITHIN NORMAL LIMITS. PATIENT OUTCOME WAS NOTED AS RESOLVED WITHOUT SEQUELAE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Required Intervention