BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INTERSTIM_INS

    MDR report key: 2653799 · Received July 12, 2012

    Report

    Report Number
    3007566237-2012-01627
    Event Type
    Injury
    Date Received
    July 12, 2012
    Date of Event
    April 19, 2012
    Report Date
    June 13, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD. (B)(4). THE ACTUAL EVENT DATES WERE NOT PROVIDED. DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    LITERATURE: PETERS, K.M., KILLINGER, K.A., GILLERAN, J., BOURA, J.A. DOES PATIENT AGE IMPACT OUTCOMES OF NEUROMODULATION? NEUROUROLOGY AND URODYNAMICS. 2012. DOI 10.1002/NAU.22268 SUMMARY: WE EVALUATED WHETHER PATIENTS STRATIFIED BY AGE HAVE THE SAME LEVEL OF RISKS/BENEFITS AFTER A STAGED NEUROMODULATION PROCEDURE FOR REFRACTORY VOIDING SYMPTOMS. PATIENTS (83% FEMALE) WERE GROUPED BY AGE (YEARS): <40 (N ¼ 46), 40-64 (N ¼ 146), AND >65 (N ¼ 136). URGE INCONTINENCE WAS PREDOMINANT IN THE OLDER GROUPS AND MORE PATIENTS <40 HAD INTERSTITIAL CYSTITIS/PAINFUL BLADDER SYNDROME (IC/PBS). IN THE <40, 40-64, AND _65 GROUPS, RESPECTIVELY, GENERATOR IMPLANT (91%, 88%, AND 89%) AND EXPLANT (15%, 12%, AND 10%) RATES WERE SIMILAR. COMPLICATIONS (24%, 14%, AND 9%; P ¼ 0.031) AND REVISIONS (20%, 5%, AND 6%; P ¼ 0.0025) DIFFERED. FOR THE THREE RESPECTIVE GROUPS, URINARY FREQUENCY (P < 0.0001 FOR ALL), NOCTURIA (P < 0.0001 FOR ALL), INCONTINENCE EPISODES (P < 0.0001 FOR ALL), URGENCY (P ¼ 0.0474, P < 0.0001, P ¼ 0.0020), ICSI-PI (P ¼ 0.0015, P < 0.0001, P < 0.0001), AND OAB-Q SCORES IMPROVED OVER TIME. INCONTINENCE SEVERITY IMPROVED IN THOSE >65 (P ¼ 0.0015). SF-12 PCS IMPROVED IN THOSE 40-64 (P ¼ 0.0482) AND MCS SCORES IMPROVED IN THE <40 AND 40-64 AGE GROUPS (P ¼ 0.013 AND P ¼ 0.0440, RESPECTIVELY). THESE DATA SUGGEST THAT NEUROMODULATION SUCCESS IS NOT AGE DEPENDENT, HOWEVER CONTINUED STUDY IS NEEDED TO CONFIRM FINDINGS. REPORTED EVENT: REVISIONS OCCURRED IN 20% OF THE >40 AGE GROUP (N = 46), 5% OF THE 40-64 AGE GROUP (N = 146), AND 6% OF THE >65 AGE GROUP (136). THE NATURE AND OUTCOMES OF THE REVISION WERE NOT REPORTED. WOUND SEROMA OCCURRED IN 4 PATIENTS. ONE PATIENT COMPLAINED OF ELECTRICAL SHOCK. SIX PATIENTS HAD LEAD BREAKAGE. SEVEN PATIENTS HAD LEAD MIGRATION. EIGHT PATIENTS HAD DEVICE MALFUNCTION. THE NATURE AND DETAILS OF THE DEVICE MALFUNCTION WERE NOT REPORTED. INFECTION OCCURRED IN 9 PATIENTS. SIX PATIENTS REQUIRED REMOVAL OF THE LEAD, AND FIVE OF THOSE PATIENTS ALSO REQUIRED REMOVAL OF THE DEVICE BATTERY. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEU_INTERSTIM_INS STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention