BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3111478 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07619
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT # VA06FGX, 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 WAS IMPLANTED LAST WEDNESDAY. IT WAS NOTED THAT IT TOOK THE PATIENT THREE PROCEDURES TO GET TO THIS POINT, INCLUDING THE TRIAL, HAVING AN ALLERGIC REACTION, AND A DELAYED PROCEDURE, AND SHE WAS FRUSTRATED. WHEN THE PATIENT WAS IN THE HOSPITAL TO GET THE IMPLANT, THEY GAVE HER BENADRYL, WHICH SHE CANNOT TAKE BECAUSE IT MADE HER FEEL LIKE SHE WAS IN AN ANT BED AND WOULD CLIMB THE WALL. THEN THE PATIENT WAS GIVEN A MUSCLE RELAXER, WHEREIN THE PATIENT WENT RIGHT TO SLEEP, AND THE DOCTOR DELAYED THE SURGERY FOUR HOURS WHILE HE SHOCKED THE PATIENT AWAKE TO DO TEMPORARY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, AND WHEN RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212791 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention