BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2983153 · Received February 28, 2013

    Report

    Report Number
    3004209178-2013-03161
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 14, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V508243, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN INFECTION. THE PATIENT HAD BEEN HOSPITALIZED 3 TIMES IN THE PAST MONTH FOR PAIN AND INFECTION SYMPTOMS. THE PATIENT WAS ADMITTED 2 DAYS AGO TO A HOSPITAL BUT WAS SENT HOME. THE PATIENT HAD NOT BEEN RECEIVING THERAPEUTIC EFFECT IN THE PAST MONTH. IT WAS ALSO STATED THE PATIENT'S SYMPTOMS HAD BEEN GETTING WORSE OVER THE PAST MONTH. THE PATIENT WAS FEELING PAIN IN THE VAGINAL AREA AND PRESSURE IN THE ABDOMEN. THE PATIENT HAD DIFFICULTIES URINATING AND WOULD "JUMP UP AND DOWN ON THE TOILET SEAT IN ORDER TO GET THE URINE OUT". THE PATIENT HAD BROKEN THE TOILET SEAT AT ONE POINT. THE REPORTER WAS WORRIED THAT THE DEVICE OR LEADS HAD MOVED FROM THE JUMPING. ONSETS OF THE PATIENT'S SYMPTOMS WERE UNCLEAR. IT WAS ALSO REPORTED THE PATIENT HAD DEMENTIA AND THE PATIENTS SYMPTOMS WERE WORSENING OVER THE PAST MONTH. THE PATIENT'S BOWEL WAS REPORTED AS NOT HAVING BEEN AFFECTED, AND PATIENT'S APPETITE SEEMED HEALTHY. THE PATIENT WAS GOING TO THE HOSPITAL THE DAY OF REPORT TO SEE IF SOMEONE COULD ADJUST THERAPY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87442 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization