BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3092619 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07287
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    January 31, 2013
    Report Date
    April 18, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# VA04V0N, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S INCISION NEVER PROPERLY HEALED AND THEY DEVELOPED AN INFECTION. THE PATIENT HAD BEEN HAVING ISSUES SINCE IMPLANT. IT WAS STATED THE PATIENT WAS ON THEIR THIRD WEEK OF ANTIBIOTICS. IT WAS NOTED THE HEALTHCARE PROVIDER TOLD THE PATIENT THAT THE "BATTERY WAS LEAKING" AND THE "DEVICE NEEDED TO BE REPLACED." IT WAS INDICATED THE PATIENT WAS HAVING A LOT OF DISCHARGE AND "WHITE OOZING FLUID" FROM THE IMPLANT SITE SINCE THE IMPLANT OF THE DEVICE. ABOUT TWO WEEKS LATER, IT WAS REPORTED THE ONSET OF THE INFECTION WAS (B)(6) 2013. THE PATIENT EXPERIENCED SYMPTOMS THAT INCLUDE REDNESS, DRAINAGE, AND POCKET EROSION. A CULTURE WAS NOT OBTAINED. A TOTAL DEVICE SYSTEM EXPLANT WAS DONE. THE DATE OF THE EXPLANT WAS UNKNOWN. THE PATIENT OUTCOME WAS LISTED AS ONGOING. IT WAS NOTED THE PATIENT HAD DIABETES, WHICH WAS INDICATED AS A RISK FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194213 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