BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2795112 · Received October 17, 2012

    Report

    Report Number
    3004209178-2012-09284
    Event Type
    Injury
    Date Received
    October 17, 2012
    Report Date
    September 19, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT # V822732, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT A PATIENT FELL, LANDED ON HER SIDE, AND IT WAS DISCOVERED THAT SHE HAD A LEAD FRACTURE. IT WAS STATED THAT THE PATIENT WAS "HAPPY" WITH HER THERAPY BEFORE THE FALL, BUT HAS HAD "TROUBLES" EVER SINCE. APPROXIMATELY TWO WEEKS LATER, IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCES ON ALL ELECTRODES DURING A PROGRAMMING SESSION. THE DEVICE WAS STILL IN THE PATIENT, BUT IT WAS TURNED OFF. A LEAD REPLACEMENT SURGERY WAS DISCUSSED, BUT AN EXACT DATE WAS NOT SCHEDULED. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COULD NOT FEEL ANY SENSATION WHEN CHANGING PROGRAMS. THE PATIENT NOTED THAT SHE DIDN'T FEEL ANY STIMULATION AND HAD A RETURN OF BLADDER SYMPTOMS. THE PATIENT'S SYMPTOMS INCLUDED URINARY FREQUENCY, BACK PAIN, BURNING WHEN URINATING. IT WAS FURTHER NOTED THAT THE PATIENT WAS TOLD THAT "HER LEADS WERE BROKEN AND SHE WOULD NEED TO HAVE SURGERY TO REPLACE THEM." THE PATIENT OUTCOME WAS NOT PROVIDED.

    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