BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2712230 · Received August 23, 2012

    Report

    Report Number
    3004209178-2012-07285
    Event Type
    Injury
    Date Received
    August 23, 2012
    Date of Event
    May 15, 2012
    Report Date
    July 26, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28 LOT#: V913910 SERIAL#: IMPLANTED: EXPLANTED: PRODUCT TYPE: LEAD PRODUCT ID: 3037 LOT#: SERIAL#: (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HER ORIGINAL DEVICE EXPLANTED IN (B)(6) 2012 DUE TO AN INFECTION. HER IMPLANTABLE NEUROSTIMULATOR (INS) AND LEAD WERE REPLACED ON (B)(6) 2012; THE INS WAS PLACED ON THE LEFT SIDE TO AVOID THE LAST INFECTED SITE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ONSET OF THE PATIENT'S INFECTION OCCURRED ON (B)(6) 2012. THE PATIENT DID NOT HAVE MENINGITIS. SYMPTOMS WERE REDNESS, SWELLING, PAIN, ITCHING, AND RASH. THE PRIMARY LOCATION OF THE INFECTION WAS IN THE DEVICE POCKET. A CULTURE WAS OBTAINED FROM THE DEVICE POCKET, AND (B)(6) WAS CULTURED. THE PATIENT WAS TREATED WITH ONE INTRAVENOUS (IV) DOSE OF ANTIBIOTICS IN THE OPERATING ROOM (OR) DURING EXPLANTATION OF HER DEVICE AND GIVEN ORAL ANTIBIOTICS AFTERWARDS. THE PATIENT'S INFECTION WAS RESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR