BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2771079 · Received October 3, 2012

    Report

    Report Number
    3004209178-2012-08861
    Event Type
    Injury
    Date Received
    October 3, 2012
    Report Date
    September 7, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 37092 LOT# 300120001 SERIAL#, IMPLANTED: 2012 (B)(6), EXPLANTED: PRODUCT TYPE ACCESSORY PRODUCT ID, 3093-28 LOT# V884821 SERIAL#, IMPLANTED: 2012 (B)(6), EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT GOT "GOOD" THERAPY EFFECT WHEN IMPLANTABLE NEUROSTIMULATOR (INS) WAS ON, BUT FELT PAIN IN PELVIC AREA, FELT "LIKE ANUS WAS PUCKERED UP" AND HAD ISSUES WITH BOWEL MOVEMENTS. PATIENT TRIED ALL FOUR PROGRAMS SINCE IMPLANT, BUT ONLY HAD SIDE EFFECTS ON SOME AND DID NOT GET THERAPEUTIC BENEFIT ON ALL PROGRAMS. STIMULATION WAS TURNED OFF FOR THREE DAYS AND PELVIC PAIN WENT AWAY, BUT SYMPTOMS OF URGENCY RETURNED. IF AMPLITUDE WAS INCREASED "TOO MUCH", PATIENT'S TOES PULLED UP AND "KNOTTED UP" AND KNEE BENT. PROGRAM THAT CYCLED 12 SEC ON/12 SEC OFF WAS PREFERRED. PATIENT GOT GOOD THERAPY DURING TRIAL WITHOUT SIDE EFFECTS. PATIENT TOOK MORPHINE PILLS TO MANAGE PAIN. IN ADDITION, DIFFICULTY TO TURN STIMULATION OFF WITH PATIENT PROGRAMMER WAS REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT SYMPTOMS WERE CAUSED BY NEUROPATHY. ORIGINAL LEAD WAS PROPERLY LOCATED PER X-RAYS ON (B)(6) 2012. REVISION WAS PERFORMED ON (B)(6) 2012 TO ADD LEAD AND EXTENSION. SYSTEM HAD "GOOD" IMPEDANCES WITH "GOOD" PATIENT RESPONSE. NO HOSPITALIZATION AND NON-SERIOUS INJURY.

    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