BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3204913 · Received July 3, 2013

    Report

    Report Number
    3004209178-2013-11270
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    June 10, 2013
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V896640, IMPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR DAYS AFTER THE DEVICE WAS IMPLANTED, THE PATIENT DEVELOPED A STAPH INFECTION. IT REPORTEDLY ¿CAME AND WENT¿ AND THERE WAS ¿ONE SPOT¿ THAT WAS PERSISTENT. THE PATIENT¿S SKIN, WHERE THE DEVICE WAS IMPLANTED, WAS RED. THE NIGHT PRIOR TO THE REPORT, IT WAS BURNING AND THE PATIENT COULDN¿T LAY ON IT. IT WAS NOTED THAT THE PATIENT PUT MEDICATION AROUND IT. TWO WEEKS LATER, IT WAS REPORTED THAT THE INFECTION WAS AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE. THE PATIENT WAS REPORTEDLY TREATED WITH KEFLEX AND BACTROBAN AND THE PATIENT GOT BETTER. THEN THE AREA BECAME RED AGAIN. THE PATIENT WAS TREATED WITH BACTROBAN TWICE FOLLOWING A SUBSEQUENT INFECTION AND THE PATIENT GOT BETTER. AFTERWARDS, THE PATIENT DEVELOPED BLISTERS ¿IN THE CORNERS¿ AND ONE ALONG THE INCISION OF THE INS. A SMALL INCISION WAS MADE BY THE PATIENT¿S HEALTHCARE PROVIDER AND PUSS WAS REMOVED FROM THE AREA. IT WAS NOTED THAT THE HCP BELIEVED THE DEVICE WOULD BE REMOVED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED. IT WAS NOTED THAT THE PATIENT DID NOT HAVE MENINGITIS. SYMPTOMS INCLUDED REDNESS, DRAINAGE, AND POCKET EROSION AT THE DEVICE POCKET. A CULTURE FOUND PSEUDOMONAS. THERE WAS A TOTAL SYSTEM EXPLANT AND THE INFECTION RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303780 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention