BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3260332 · Received August 1, 2013

    Report

    Report Number
    3004209178-2013-12654
    Event Type
    Injury
    Date Received
    August 1, 2013
    Report Date
    July 9, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT# V115606, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FORMED A KELOID SCAR AT THE INCISION SITE. THE PATIENT WAS SCRATCHING THE SCAR AND THE LEAD REPORTEDLY BECAME EXPOSED THROUGH THE SCAR. THE EVENT WAS ATTRIBUTED TO THE LEAD. IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) AND THE LEAD WERE EXPLANTED FOLLOWED BY A ¿COMBINED I/II¿ IMPLANT LATER. IT WAS NOTED THAT THE PATIENT DID NOT REQUIRE HOSPITALIZATION DUE TO THE EVENT AND RECOVERED WITHOUT SEQUELAE. IT WAS LATER REPORTED THAT THE KELOID SCAR WAS FIRST NOTICED AT THE PATIENT¿S APPOINTMENT ON (B)(6) 2013, BUT IT WAS NOTED THAT IT WAS NOT AN ISSUE AT THAT POINT. THE REPORTER STATED THAT THE PATIENT WAS SCRATCHED AT THE KELOID SCAR AND THE LEAD WAS COMING OUT WHEN THE PATIENT WAS SEEN ON (B)(6) 2013. THE ENTIRE SYSTEM WAS THEN EXPLANTED ON THE FOLLOWING DAY. THE PHYSICIAN STATED THAT THE BATTERY WAS NOT DEPLETED, BUT IT WAS ¿LOW ENOUGH¿ TO BE REPLACED AT THAT TIME. A NEW INS AND LEAD WERE IMPLANTED ON (B)(6) 2013. THE PATIENT WAS REPORTEDLY HAPPY WITH THE RESULTS WITH THE NEW SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360447 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention