BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5451097 · Received February 22, 2016

    Report

    Report Number
    3007566237-2016-00916
    Event Type
    Injury
    Date Received
    February 22, 2016
    Date of Event
    January 1, 2013
    Report Date
    June 23, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. (B)(4). PLEASE NOTE THIS DATE IS AN ESTIMATE BASED OFF OF THE REPORTED "2013 (B)(6)" SKIING ACCIDENT. DATE OF EVENT: 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.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    WÖLLNER, J., PANNEK, J. SACRAL NEUROMODULATION: NO MORE SKIING? SCAND J UROL. 2016:1¿2. DOI: 10.3109/21681805.2015.1119189. SUMMARY: PATIENTS WITH SPINAL CORD INJURY (SCI) COMMONLY SUFFER FROM NEUROGENIC LOWER URINARY TRACT DYSFUNCTION (NLUTD). SACRAL NEU ROMODULATION (SNM) OFFERS AN ALTERNATIVE IN THE TREATMENT OF DETRUSOR OVERACTIVITY IN PATIENTS WITH NLUTD. WE REPORT THE CASES OF THREE PATIENTS WITH NLUTD DUE TO SCI WHO RECEIVED SNM. DUE TO TREATMENT SUCCESS, ALL PATIENTS COULD RESUME SKIING. ALL SUFFERED FROM SKIING ACCIDENTS, LEADING TO A DECREASED EFFECTIVENESS OF SNM. SUBSEQUENT EVALUATION REVEALED A DEFECT OF THE IMPULSE GENERATOR (IPG) AND/OR DISLOCATION OF THE ELECTRODES. REPROGRAMMING OR REPLACEMENT OF THE IPG OR THE ELECTRODES RESULTED IN RESTORATION OF SNM FUNCTION. TRAUMA DUE TO SKIING IS A POTENTIAL RISK FACTOR FOR THE INTEGRITY OF SNM. PATIENTS WITH SNM SHOULD BE INFORMED ABOUT THE POTENTIAL RISK OF SNM DAMAGE BY FALLS AND ACCIDENTS. REPORTED EVENTS: IT WAS REPORTED A (B)(6) WOMAN WITH NEUROGENIC DETRUSOR OVERACTIVITY (NDO) FOLLOWING A 2010 COMPLETE TRAUMATIC SPINAL CORD INJU RY (SCI), LESION LEVEL T5, WAS IMPLANTED WITH A BILATERAL SACRAL NEUROMODULATION (SNM) SYSTEM IN 2011(B)(6) AFTER A SUCCESSFUL TEST PHASE WITH BILATERAL S3 ELECTRODES. WHILE USING THE DEVICE AND INTERMITTENT SELF-CATHETERIZATION (IC) FOUR OR FIVE TIMES PER DAY (VOLU MES: 300-500 ML) THE PATIENT ACHIEVED COMPLETE CONTINENCE. IN COMBINATION WITH 8 MG FESOTERODINE, NDO WAS SUCCESSFULLY SUPPRESSED. HOWEVER, ¿IN (B)(6) 2013, SHE SUFFERED FROM A SIT-SKIING ACCIDENT WITH CONTUSION OF THE RIGHT GLUTEAL REGION. SUBSEQUENTLY, SHE REPORTED A DECREASED BLADDER CAPACITY (200¿300 ML) AND INCONTINENCE. URODYNAMICS REVEALED INCREASED NDO. IT WAS IMPOSSIBLE TO CONNECT THE IMPLANTABLE PULSE GENERATOR (IPG) WITH THE EXTERNAL CONTROLLER. ASSUMING A TECHNICAL DEFECT, THE IPG WAS REPLACED. DURING SURGERY ADDITIONAL AREAS OF DAMAGE WERE OBSERVED ON BOTH LEADS, WHICH WERE NOT VISIBLE ON FLUOROSCOPY. THUS, BOTH ELECTRODES WERE REPLACED. AT FOLLOW-UP, THE PATIENT REGAINED COMPLETE CONTINENCE AND THE IC VOLUMES INCREASED TO 400¿700 ML.¿ FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION NOTED A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107708 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3058 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00022 YR Required Intervention