BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4638204 · Received March 27, 2015

    Report

    Report Number
    3004209178-2015-05534
    Event Type
    Injury
    Date Received
    March 27, 2015
    Date of Event
    March 5, 2015
    Report Date
    March 5, 2015
    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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID NEU_UNKNOWN_LEAD, IMPLANTED: 2015-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 357506, LOT# 50720427, PRODUCT TYPE SCREENING DEVICE, PRODUCT ID 041829, LOT# 50855244, PRODUCT TYPE ACCESSORY. PRODUCT ID 3889-41, LOT# VA0F6WM, IMPLANTED: 2014-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4). ANALYSIS OF THE J-HOOK TEST CABLE (357506) FOUND NO ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NOT A 50 PERCENT OR GREATER SYMPTOM REDUCTION FOR THE PATIENT. THAT WAS WHY THE LEAD WAS REVISED, BECAUSE IT HAD MIGRATED. THE COMPONENT INVOLVED IN THE EVENT WAS THE LEAD. IT WAS UNKNOWN IF THE CAUSE OF THE EVENT WAS DETERMINED. THE PATIENT WAS TRAILING A NEW LEAD NOW THROUGH AN ADVANCED EVALUATION. THE LEAD WAS REPLACED AND WAS NOT RETURNED. ONLY THE TEST CABLE AND THE FORAMEN NEEDED WERE REMOVED AND WOULD BE RETURNED. THE J-HOOK TEST CABLE AND THE FORAMEN NEEDLE HAD INTERMITTENT STIMULATION DURING THE PROCEDURE AND THE ACTION REQUIRED AS A RESULT OF THE EVENT WAS REPLACEMENT. DIAGNOSTIC TESTING OR TROUBLESHOOTING OF AN EMG WAS PERFORMED. THERE WAS NO STIMULATION AND WHEN THEY MOVED THE WIRE A LITTLE BIT THEY HAD STIMULATION AGAIN. THIS WAS CONFIRMED BY THE EMG. THE ISSUE WAS RESOLVED AND THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE J-HOOK TEST CABLE WAS USED 5 DAYS AFTER THE USE BEFORE DATE. THE PATIENT STATUS WAS ALIVE WITH NO INJURY. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THE EVENT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206728 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention