BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 14654646 · Received June 10, 2022

    Report

    Report Number
    2182207-2022-01052
    Event Type
    Injury
    Date Received
    June 10, 2022
    Date of Event
    October 7, 2021
    Report Date
    June 10, 2022
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED.¿ CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_INS_STIMULATOR, LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT#: UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT#: UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT#: UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT#: UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT#: UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT#: UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT#: UNKNOWN, PRODUCT TYPE LEAD. PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT#: UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT#: UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT#: UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT#: UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT#: UNKNOWN, PRODUCT TYPE LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT#: UNKNOWN, PRODUCT TYPE LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT#: UNKNOWN, PRODUCT TYPE LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN ; PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN; PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ALGHAFEES. M., GHAZWANI. Y., ALQAHTANI. M., ALDARRAB. R. TRENDS AND OUTCOMES OF SACRAL NEUROMODULATION: A SAUDI TERTIARY CARE CENTER EXPERIENCE. JOURNAL OF UROLOGICAL SURGERY JO - J UROL SUR. 2022;9(1):25 - 32. DOI: 10.4274/JUS.GALENOS.2021.2021.0068. SACRAL NEUROMODULATION (SNM) IS A VALIDATED TREATMENT FOR OVERACTIVE BLADDER SYNDROME AND CHRONIC NON-OBSTRUCTIVE RETENTION. IN SAUDI ARABIA, SNM IS GAINING POPULARITY. IT IMPROVES PATIENT OUTCOMES AND ELIMINATES THE ASSOCIATED STIGMA WITH REFRACTORY URINE RETENTION. THIS STUDY AIMED TO ASSESS THE TRENDS AND OUTCOMES IN PATIENTS WITH SNM IN KING ABDULAZIZ MEDICAL CITY. THIS RETROSPECTIVE COHORT STUDY TARGETED ADULT PATIENTS WHO UNDERWENT AN SNM DEVICE IMPLANTATION BETWEEN JANUARY 1, 2016, AND JANUARY 1, 2021. FREQUENCY AND PERCENTAGE WERE USED TO DISPLAY THE CATEGORICAL VARIABLES AND MINIMUM, MAXIMUM, MEAN, AND STANDARD DEVIATION FOR THE CONTINUOUS VARIABLES. OF THE 28 PATIENTS, 13 (46.4%) WERE MALES AND 15 (53.6%) FEMALES. THE MEAN AGE WAS 37.14+14.62 YEARS. THE MOST FREQUENT INDICATION WAS IDIOPATHIC BLADDER DYSFUNCTION (28.6%, N=8). THE FIRST STAGE SUCCESS RATE WAS 53.6%, OF WHICH 42.9% HAD THE DEVICE PERMANENTLY IMPLANTED IN THE SECOND STAGE. THE OVERALL COMPLICATION RATES WERE 66.6% AND 42.84% FOR DEVICE CHANGE AND ELECTRODE CHANGE, RESPECTIVELY, WITH THE MOST FREQUENT COMPLICATIONS AS DEVICE PROTRUSION AND DISLOCATION AFTER DEVICE CHANGE (N=1, 33.3%) AND URINARY TRACT INFECTIONS AFTER ELECTRODE CHANGE (N=3, 21.42%). THE COMPLICATION RATE WAS SIMILAR TO THE LITERATURE. HOWEVER, THE FIRST STAGE SUCCESS RATE WAS LOWER THAN THE REPORTED LOCAL AND INTERNATIONAL RATES. REGULAR DOCUMENTATION BEFORE AND AFTER IMPLANTATION IS IMPORTANT TO GATHER DATA FOR FUTURE STUDIES. EXPLORING THE OUTCOMES OF SNM ON A LARGER SCALE WILL IMPROVE PREOPERATIVE, PERIOPERATIVE, AND POSTOPERATIVE CARE, THEREBY SUPPORTING MORE PATIENT SATISFACTION. REPORTED EVENTS: 1. ONE PATIENT DEVICE PROTRUSION FROM INCISION SITE WITH MINIMAL DISCHARGE WITHIN 28 MONTHS AND DEVICE CHANGED. 2. ONE PATIENT BULGING OF THE DEVICE, WITH PAIN AROUND THE DEVICE AND MILD TENDERNESS WITHIN 42 MONTHS DEVICE CHANGED. 3. ONE PATIENT WITH ELECTRODE CHANGE FOR ELECTRODE CHANGE/READJUSTMENT IN THE FIRST-TIME EXPERIENCED TRAUMA AT THE SITE OF THE DEVICE FOLLOWED BY AN INTERRUPTED STREAM WITHIN 3 MONTHS. 4. SAME PATIENT HAD ELECTRODE CHANGE THE SECOND TIME FOR ELECTRODE CHANGE/READJUSTMENT IN THE FIRST-TIME EXPERIENCED DEVICE EROSION AND MALFUNCTION WITHIN 9 MONTHS. 5. ONE PATIENT WITH ELECTRODE CHANGES FOR THREE TIMES; DISPLACEMENT OF THE DEVICE WITHIN 1.5-MONTHS. 6. DISPLACEMENT OF THE ELECTRODE CHANGE/READJUSTMENT FOLLOWED BY HESITANCY AND NOT FEELING THE VIBRATIONS WITH 21 MONTHS. 7. AND DISPLACED ELECTRODE CHANGE/READJUSTMENT WITHIN 25 MONTHS. 8. ONE PATIENT WITH ELECTRODE CHANGES NINE TIMES FOR ELECTRODE CHANGE/READJUSTMENT: PAIN AT THE SITE OF THE DEVICE WITH 12 MONTHS WITH URINARY INCONTINENCE. 9. URINARY INCONTINENCE WITHIN 4 MONTHS THE SECOND TIME WITH URINARY TRACT INFECTION COMPLICATION AND ELECTRODE CHANGE/READJUSTMENT. 10. THE THIRD TIME EROSION OF THE DEVICE WITHIN 2 MONTHS WITH URINARY TRACT INFECTION COMPLICATION AND ELECTRODE CHANGE/READJUSTMENT. 11. THE FOURTH TIME EXPERIENCED SUPERFICIALLY PALPABLE DEVICE WITH PAIN WITHIN 4 MONTHS AND ELECTRODE CHANGE/READJUSTMENT. 12. THE FIFTH TIME DISPLACEMENT OF ELECTRODES INDICATED THE WIRE EXPOSED FROM THE WOUND WITH MINIMAL DISCHARGE WITHIN 7 MONTHS AND ELECTRODE CHANGE/READJUSTMENT. 13. THE SIXTH-TIME EXPOSED WIRE WITHIN 1.5 MONTHS AND ELECTRODE CHANGE/READJUSTMENT. 14. THE SEVENTH TIME EXPERIENCED THE LOWER LEG NUMBNESS TRIGGERED BY TURNING THE DEVICE ON WITHIN 12 MONTHS AND ELECTRODE CHANGE/REA DJUSTMENT. 15. THE EIGHTH TIME PROTRUDING OF ELECTRODE WITH 11 MONTHS ELECTRODE CHANGE/READJUSTMENT. 16. THE NINTH-TIME PROTRUDING OF ELECTRODE WITH 11 MONTHS WITH URINARY TRACT INFECTION COMPLICATION AND ELECTRODE CHANGE/READJUSTMENT. NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2449317 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention