BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 9741631 · Received February 21, 2020

    Report

    Report Number
    6000030-2020-00043
    Event Type
    Injury
    Date Received
    February 21, 2020
    Date of Event
    December 24, 2019
    Report Date
    February 21, 2020
    Manufacturer
    RICE CREEK MFG
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: DODGE NA, LINDER BJ. TECHNIQUES FOR OPTIMIZING LEAD PLACEMENT DURING SACRAL NEUROMODULATION. INTERNATIONAL UROGYNECOLOGY JOURNAL. 2019. 10.1007/S00192-019-04208-0. DATE OF EVENT: PLEASE NOTE THIS DATE IS BASED OFF OF THE ARTICLE¿S PUBLICATION DATE AS THE SPECIFIC EVENT DATE WAS NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENTS WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT MEDICAL DEVICES: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT#: UNKNOWN, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN, UBD: ASKU, UDI#: ASKU. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    LITERATURE ABSTRACT: A (B)(6) YEAR-OLD FEMALE PRESENTED WITH URINARY URGENCY INCONTINENCE REFRACTORY TO BEHAVIORAL MODIFICATION, PHYSICAL THERAPY, AND ORAL PHARMACOTHERAPY. AN STIMULATION DEVICE HAD BEEN PLACED 3 YEARS PRIOR BY ANOTHER PROVIDER, BUT THE PATIENT DID NOT FIND IT BENEFICIAL AND HAD UNCOMFORTABLE STIMULATION DESPITE REPROGRAMMING. AFTER COUNSELING, SHE OPTED FOR DEVICE REVISION. THE S3 FORAMEN IS IDENTIFIED USING FLUOROSCOPY IN ANTERIOR-POSTERIOR AND LATERAL VIEWS; A NEEDLE IS ADVANCED THROUGH THE CEPHALAD AND MEDIAL ASPECT OF THE FORAMEN AND TESTED FOR BELLOWS AND TOE RESPONSES. AFTER THE DIRECTIONAL GUIDE IS PLACED, THE INTRODUCER IS ADVANCED UNTIL IT IS MIDWAY THROUGH THE BONY TABLE. THE LEAD, WITH A CURVED STYLET, IS ADVANCED FOR REPEAT TESTING PRIOR TO DEPLOYMENT. IT SHOULD HAVE A CEPHALAD-TO-CAUDAD APPEARANCE AND CURVE LATERALLY. MOTOR RESPONSES ARE TESTED AND OPTIMALLY SHOULD BE 2 V WITH ALL ELECTRODES. THE LEAD IS THEN ADVANCED FULLY, DEPLOYED, AND RETESTED. THE PATIENT¿S DAYTIME FREQUENCY IMPROVED TO 6 PER DAY FROM 11 PER DAY AT BASELINE; HER URGENCY INCONTINENCE AND THE UNCOMFORTABLE STIMULATION RESOLVED. OPTIMIZATION OF LEAD PLACEMENT FOR SACRAL NEUROMODULATION IS CRUCIAL FOR IMPROVING CLINICAL RESULTS. REPORTED EVENT: A (B)(6) YEAR-OLD FEMALE PRESENTED WITH URINARY URGENCY INCONTINENCE REFRACTORY TO BEHAVIORAL MODIFICATION, PHYSICAL THERAPY, AND ORAL P HARMACOTHERAPY. THREE YEARS PRIOR TO REPORT, SHE PROGRESSED TO SACRAL NERVE STIMULATOR PLACEMENT WITH HER LOCAL PROVIDER. SHE INITIALLY FELT THAT THIS WAS HELPFUL, BUT SOON AFTER PLACEMENT NOTED MARGINAL BENEFIT WITH DAYTIME FREQUENCY OF 11 VOIDS/DAY AND TWO URGENCY INCONTINENCE LEAKS PER DAY. FURTHERMORE, SHE REPORTED AN UNCOMFORTABLE STIMULATION IN HER RIGHT GROIN, RADIATING DOWN HER LEG SINCE PLACEMENT THAT PERSISTED DESPITE MULTIPLE ATTEMPTS AT REPROGRAMMING. THIS SENSATION RESOLVED WHEN THE DEVICE WAS TURNED OFF. DEVICE INTERROGATION REVEALED NORMAL IMPEDANCES, WITH LIMITED BATTERY LIFE REMAINING. PELVIC X-RAYS, INCLUDING ANTERIOR-POSTERIOR AND LATERAL VIEWS, WERE OBTAINED TO EVALUATE THE LOCATION OF THE LEAD. THE LEAD WAS NOTED TO BE MEDIAL IN THE S3 FORAMEN; HOWEVER, SEVERAL OF THE ELECTRODES WERE WITHIN THE BONY TABLE, AND THE LEAD WAS NOT ORIENTED IN A CEPHALAD-TO-CAUDAD DIRECTION. THE PATIENT WAS COUNSELED REGARDING OPTIONS, INCLUDING SWITCHING TO OTHER FORMS OF THIRD-LINE OVERACTIVE BLADDER THERAPY (POSTERIOR TIBIAL NERVE STIMULATION OR INTRADETRUSOR INJECTION OF ONABOTULINUMTOXINA) OR REVISION OF HER LEAD AND IMPLANTABLE NEUROSTIMULATOR (INS), AND SHE ULTIMATELY ELECTED FOR THE LATTER. FOLLOWING THE REVISION, THE PATIENT EXPERIENCED AN IMPROVEMENT IN HER OVERACTIVE BLADDER SYMPTOMS WITH A REDUCTION OF DAYTIME FREQUENCY FROM 11 TO 6 VOIDS/DAY AND RESOLUTION OF HER URINARY URGENCY INCONTINENCE. SHE ALSO NOTED RESOLUTION OF THE UNCOMFORTABLE GROIN STIMULATION AND SUBSEQUENTLY FELT AN APPROPRIATE VAGINAL SENSATION, WITHOUT ANY RADIATION DOWN HER LEG. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202895 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW RICE CREEK MFG NEU_INTERSTIM_INS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention