BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3133665 · Received May 29, 2013

    Report

    Report Number
    3007566237-2013-01770
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 6, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 IN SECTION A IS AN AVERAGE FOR ALL THE PATIENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_INTERSTIM_INS, SERIAL# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID NEU_INTERSTIM_INS, SERIAL# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID NEU_INTERSTIM_INS, SERIAL# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID NEU_INTERSTIM_INS, SERIAL# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD: PRODUCT ID NEU_INTERSTIM_INS, SERIAL# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID NEU_INTERSTIM_INS, SERIAL# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID NEU_INTERSTIM_INS, SERIAL# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID NEU_INTERSTIM_INS, SERIAL# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID NEU_INTERSTIM_INS, SERIAL# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID NEU_INTERSTIM_INS, SERIAL# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD: PRODUCT ID NEU_INTERSTIM_INS, SERIAL# UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    SHIH, C., MILLER, J. L., FIALKOW, M., VICARS, B. G., YANG, C. C. REOPERATION AFTER SACRAL NEUROMODULATION THERAPY: A SINGLE-INSTITUTION EXPERIENCE. FEMALE PELVIC MEDICINE & RECONSTRUCTIVE SURGERY. 2013;19(3):175-178. DOI: 10.1097/SPV.0B013E31828AB3C9. SUMMARY:WE PERFORMED A RETROSPECTIVE REVIEW OF OUR PATIENTS WHO HAD UNDERGONE THE IMPLANTATION OF THE INTERSTIM DEVICE FROM APRIL 1999 TO DECEMBER 2011 FOR LOWER URINARY TRACT DYSFUNCTION. A TOTAL OF 155 INTERSTIM DEVICES WERE IMPLANTED BY 2 SURGEONS. OF THE 142 PATIENTS WITH COMPLETE FOLLOW-UP, 55 (38.2%) PATIENTS REQUIRED REOPERATION, FOR EITHER REVISION OR EXPLANTATION OF THE DEVICE. REVISIONS WERE PERFORMED IN 30 (21.1%) PATIENTS, MOST COMMONLY FOR MECHANICAL FAILURE OF DEVICE, BATTERY END-OF-SERVICE, AND PAIN, EITHER AT THE SITE OF THE IMPLANTED PULSE GENERATOR OR WITH STIMULATION. OF THE 30 PATIENTS WHO UNDERWENT REVISION, 14 HAD SUCCESSFUL RESULTS, 6 HAD PERSISTENT SYMPTOMS, AND 10 PROGRESSED TO EVENTUAL EXPLANTATION. THE OVERALL EXPLANTATION RATE WAS 24.6% (35 OF 142 PATIENTS), AND THE AVERAGE TIME TO REMOVAL WAS 44 MONTHS. MOST OF THE EXPLANTATIONS WERE PERFORMED FOR POOR SYMPTOM CONTROL AND FAILURE TO MAINTAIN RESPONSE (74.3%). REOPERATION WAS NOT ASSOCIATED WITH AGE, SEX, OBESITY, DIABETES, CHRONIC PAIN, USE OF THE TINED LEAD, OR TYPE OF LOWER URINARY TRACT DYSFUNCTION. SACRAL NEUROMODULATION HAS A SUBSTANTIAL REVISION AND EXPLANTATION RATE, WITHOUT ANY CLEAR PREDICTORS FOR THESE COMPLICATIONS. PATIENTS SHOULD BE COUNSELED TO THESE COMPLICATIONS BEFORE SURGERY. REPORTED EVENTS: 6 PATIENTS HAD A REVISION DUE TO MECHANICAL FAILURE WHICH INCLUDED A PRESUMPTION OF DEVICE MALFUNCTION IF WHEN THERE WAS A SUDDEN LOSS OF EFFICACY AFTER A PERIOD OF SUCCESSFUL RESULTS. TEN PATIENTS HAD A REVISION DUE TO PAIN AT THE SITE OF THE IMPLANTED PULSE GENERATOR. SIX PATIENTS HAD A REVISION DUE TO PAINFUL STIMULATION. THREE PATIENTS HAD A REVISION DUE TO POOR SYMPTOM CONTROL. TWO PATIENTS HAD A REVISION DUE TO LEAD MIGRATION. TWO PATIENTS HAD A REVISION DUE TO AN INFECTION. TWENTY-FIVE PATIENTS HAD THEIR DEVICE EXPLANTED DUE TO POOR RESULTS/FAILURE TO MAINTAIN RESPONSE. EIGHT PATIENTS HAD THEIR DEVICE EXPLANTED DUE TO EITHER PAIN AT THE SITE OF THE IMPLANTED PULSE GENERATOR OR PAINFUL STIMULATION. ONE PATIENT HAD THEIR DEVICE EXPLANTED DUE TO DEVICE EROSION. SIXTEEN PATIENTS HAD THERE DEVICE EXPLANTED PARTLY DUE TO THE NEED TO HAVE AN MRI NOTE: OF THE PATIENTS WHO HAD REVISIONS, 14 HAD SUCCESSFUL RESULTS, 6 PATIENTS HAD PERSISTENT SYMPTOMS, AND 10 WENT ON TO HAVE THEIR DEVICE EXPLANTED. HOWEVER, IT WAS UNKNOWN TO WHICH SPECIFIC PATIENTS THE OUTCOMES REFERRED. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. PLEASE REFER TO MANUFACTURES REPORT # 3007566237-2013-01769 FOR ADDITIONAL INFORMATION ON A RELATED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236029 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention