BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3224799 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-11706
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 18, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3093-28, LOT# V855059, IMPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SIX SUTURES PLACED AFTER IMPLANT. THE SUTURES WERE REMOVED ON (B)(6) 2013 AND WOUND HAD NO SIGNS OF INFECTION. THE PATIENT LEFT ON A TRIP ON (B)(6) 2013 AND THE WOUND REOPENED ON (B)(6) 2013. THE PATIENT ¿LOST QUITE A BIT OF BLOOD¿ AND WAS TAKEN TO THE EMERGENCY ROOM (ER). THE WOUND WAS ¿RESUTURED¿ WITH TEN SUTURES. THE PATIENT WAS PLACED ON AN ANTIBIOTIC, ¿SEPTRA DS,¿ AND IT WAS STATED THAT A ¿HEMATOMA FORMED DURING THE PROCEDURE.¿ THE PATIENT RETURNED ON (B)(6) 2013 AND FOLLOWED UP WITH HER PRIMARY HEALTH CARE PROVIDER (HCP) ON (B)(6) 2013. THE PATIENT WAS CLEANING AND DRESSING THE WOUND EVERY DAY. THE PATIENT CONTINUED ON HER ORIGINAL ANTIBIOTIC AND WAS ALSO GIVEN ¿CEPHALEXIN.¿ THE PATIENT¿S HCP WANTED TO KEEP THE SUTURES IN FOR ¿AS LONG AS POSSIBLE.¿ THE PATIENT HAD ALREADY LOST THREE SUTURES AND THE INCISION LOOKED RED, INDURATED, AND WARM. THE REPORTER THOUGHT IT HAD NOTHING TO DO WITH THE DEVICE. IT WAS REPORTED THAT A HCP IN THE E.R. STATED IT WAS FROM ¿A HEMATOMA FROM THE PROCEDURE. THE PATIENT WAS ON PLAVIX AND IF IT WAS FULL AND IT FILLED UP LIKE A BALLOON ONCE THE SUTURES WERE REMOVED.¿ THE PATIENT HAD WOUND DEHISCENCE AFTER THE IMPLANT AND THE SUTURES WERE REMOVED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT UNIT CONTINUES TO FUNCTION WELL. IT WAS NOTED THAT THE WOUND OPENED UP DUE TO PRESSURE FROM TRAVELING MORE THAN 10 HOURS, WAS RE-SUTURED, HEALED WELL, AND THE UNIT WAS STILL IN PLACE. THE PATIENT DID NOT REQUIRE HOSPITALIZATION AND THE PATIENT OUTCOME WAS NOTED AS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322171 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Required Intervention