BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2801804 · Received October 23, 2012

    Report

    Report Number
    3004209178-2012-09441
    Event Type
    Injury
    Date Received
    October 23, 2012
    Report Date
    September 30, 2012
    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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3889-28 LOT# V885623, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STARTING IN MID-AUGUST THE PATIENT HAD BEEN WAKING UP IN THE MIDDLE OF THE NIGHT WITH BACK PAIN AND URINATING 4-5 TIMES, WHICH WAS SIMILAR TO BEFORE THE IMPLANT. THE PATIENT ALSO EXPERIENCED EXCRUCIATING PAIN IN THE MIDDLE AND LEFT SIDE OF HER ABDOMEN / BLADDER AREA FOLLOWING INTERCOURSE. IT WAS ALSO REPORTED THAT NO MATTER WHAT PROGRAM / SETTING, THE PATIENT EXPERIENCED STIMULATION DOWN HER LEG AND HER TOES WENT NUMB. IT WAS REPORTED THAT THIS WAS REALLY PAINFUL AND THE PATIENT HAD TRIED ALL OF THE PROGRAMS WITH NO SUCCESS OF STIMULATION IN THE PROPER LOCATION. IT WAS LATER REPORTED THAT THE PATIENT WAS SCHEDULED TO HAVE HER LEAD REVISED ON (B)(6) BECAUSE, THEY WERE TOO CLOSE TO THE NERVES THAT WERE DOWN IN HER LEGS AND GAVE HER CONSTANT PAIN AND MADE HER TOES NUMB. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    THE PATIENT OUTCOME WAS REPORTED AS RECOVERED WITHOUT PERMANENT IMPAIRMENT. IT WAS INDICATED THAT PATIENT WAS TO RETURN IN 2 MONTHS AND APPOINTMENT WAS SCHEDULED FOR (B)(6) 2015.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT IN JUNE 2013 THEY REPLACED THE PATIENT¿S DEVICE AND MOVED IT TO THE OTHER SIDE. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. REFER TO MANUFACTURER'S REPORT # 3004209178-2014-05877 FOR THE SAME THING HAPPENING WITH THE PATIENT'S NEW INS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention