BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3225315 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-11717
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 19, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V952224, IMPLANTED: (B)(6) 2012: PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4): PRODUCT TYPE PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD A REVISION ON 2013 (B)(6). THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS AT AN ¿OBLIQUE¿ ANGLE IN THE POCKET AT THE TIME OF THE REVISION. THE INS AND TINED LEAD WERE LAID ¿FLAT¿ DURING THE PROCEDURE WITHOUT ANY DIFFICULTY. THE PATIENT TOLERATED THE PROCEDURE WITHOUT COMPLICATION AND WENT TO RECOVERY IN STABLE CONDITION. THE PATIENT OUTCOME WAS NO INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE TURNED IN THE POCKET, WAS STICKING OUT, AND THE PATIENT HAD PAIN AT THE DEVICE SITE, WHICH OCCURRED FOLLOWING A FALL TWO WEEKS AGO. IT WAS NOTED THAT FOUR DAYS AFTER THE FALL, THE PATIENT¿S HUSBAND NOTICED THE AREA AROUND THE DEVICE POCKET WAS SWOLLEN. THE PATIENT SAW HER PHYSICIAN, WHO FELT THE PATIENT¿S BACK AND CONFIRMED THE DEVICE WAS FLIPPED AS WELL AS OF OUT OF PLACE. IT WAS NOTED THAT THE PATIENT¿S PHYSICIAN WAS OUT OF THE COUNTRY AND THE PATIENT WAS LOOKING FOR ANOTHER PHYSICIAN, AS SHE COULD NOT WAIT UNTIL HER PHYSICIAN RETURNED. THE PATIENT WAS CONCERNED ABOUT FURTHER DAMAGE TO THE DEVICE IF LEFT UNTREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323417 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR Required Intervention