BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2927439 · Received January 23, 2013

    Report

    Report Number
    3007566237-2013-00266
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    April 18, 2012
    Report Date
    January 2, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS 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. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. THE PATIENT INFORMATION PROVIDED IS AN AVERAGE FOR ALL THE PATIENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    DENZINGER, S., NOWROTEK, A., WEINGART, P., BURGER, M., WIELAND, W. F., ROBLER, W., OTTO, W. DOES SACRAL NEUROMODULATION LEAD TO RELEVANT REDUCTION IN THE NEED FOR INTERMITTENT CATHETERIZATION? A SINGLE-CENTER EXPERIENCE ON PATIENTS WITH CHRONIC URINARY RETENTION.NEUROMODULATION :JOURNAL OF THE INTERNATIONAL NEUROMODULATION SOCIETY. 2012;15(6):586-591. DOI: 10.1111/J.1525-1403.2012.00465.X. SUMMARY: FROM OCTOBER 2007 TO DECEMBER 2010, A COHORT OF 20 PATIENTS RECEIVED TWO-STAGE INTERSTIM TINED-LEAD (MEDTRONIC INC., (B)(4) USA) SNM THERAPY FOR UR. THE NUMBER OF ELECTRODES IMPLANTED WAS DECIDED BY SURGEONS ON THE BASIS OF PATIENTS' CLINICAL PRESENTATION AND EXTENT OF UR. DEPENDENT ON THE TREATMENT SUCCESS, PATIENTS RECEIVED EITHER IMPLANTATION OF THE IMPLANTABLE PULSE GENERATOR (IPG) OR THE ELECTRODES WERE REMOVED. MEDIAN FOLLOW-UP TIME WAS 12 MONTHS (1-38 MONTHS). ALL 20 PATIENTS, OF WHOM 80% WERE FEMALE, SUFFERED FROM IDIOPATHIC OR NEUROGENIC UR FOR A MEDIAN 60 MONTHS (7-440 MONTHS) BEFORE SNM. MEDIAN PATIENT AGE WAS (B)(6). EIGHTEEN (90%) OF THE STIMULATED PATIENTS SHOWED SIGNIFICANT SUCCESS WITH IMPLANTATION OF IPG WITHIN A MEDIAN OF 43 DAYS (15-93). IN THE FOLLOW-UP PERIOD, POSTVOID RESIDUAL (PVR) URINE OF THE PERMANENT STIMULATED PATIENTS WAS REDUCED FROM A MEDIAN OF 350 ML TO 135 ML. WHILE THIS JUST DID NOT REACH STATISTICAL SIGNIFICANCE (P=0.057), THE MEDIAN NUMBER OF INTERMITTENT CATHETERIZATIONS (ICS) COULD BE REDUCED RELEVANTLY FROM FOUR TO ONE PER DAY (P=0.021). THE SUBGROUP ANALYSIS OF IDIOPATHIC AND NEUROGENIC UR SHOWED RELEVANT IMPROVEMENT OF THE VITAL PARAMETERS, BUT THE NUMBER OF PATIENTS WAS OBVIOUSLY TOO SMALL TO YIELD STATISTICALLY SIGNIFICANT RESU LTS. SUBGROUP ANALYSIS ACCORDING TO THE NUMBER OF ELECTRODES IMPLANTED REVEALED STATISTICALLY SIGNIFICANT REDUCTION OF IC ONLY AFTER UNILATERAL SNM. PVR OF _400 ML WAS A STATISTICALLY SIGNIFICANT PREDICTOR FOR SUCCESS OF SNM TREATMENT. IN THE PRESENTED TREATMENT PERIOD, ONLY ONE MILD ADVERSE EVENT OCCURRED THAT COULD BE HANDLED CONSERVATIVELY. REPORTED EVENT: 2 PATIENTS UNDERWENT REVISION TO TRANSFER THE INS FROM GLUTEAL TO ABDOMINAL SUBCUTANEOUS TISSUE. THE REVISIONS WERE DUE TO THE PATIENTS LOSING EXCESSIVE WEIGHT WHICH LED TO PROBLEMS WITH LYING AND SITTING ON THE INS. ONE PATIENT WHO SUFFERED FROM URINARY RETENTION SINCE CHILDHOOD DID NOT SHOW ANY CLINICAL IMPROVEMENT AND THE ELECTRODE WAS EXPLANTED. ONE PATIENT WITH URINARY RETENTION FOLLOWING RADICAL RECTAL CANCER EXTIRPATION HAD NO IMPROVEMENT IN HIS POSTVOID RESIDUAL AND WAS EXPLANTED. ONE PATIENT DEVELOPED A PHLEGMONOUS INFECTION AT THE END OF THE TESTING PERIOD WHICH WAS HANDLED CONSERVATIVELY. 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
    32451 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention