BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM NEUROSTIMULATOR, UNKNOWN

    MDR report key: 5258080 · Received December 1, 2015

    Report

    Report Number
    3007566237-2015-03540
    Event Type
    Injury
    Date Received
    December 1, 2015
    Report Date
    November 2, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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

    AGE: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED 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 PRODUCTS: PRODUCT ID NEU_INTERSTIM_INS, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_INTERSTIM_INS, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    SINGH, R., EL NASHAR S.A., TRABUCO EC, KLINGELE CJ, GEBHART JB, OCCHINO JA. COMPARISON OF SHORT TERM OUTCOMES OF SACRAL NERVE STIMULATION AND INTRADETRUSOR INJECTION OF ONABOTULINUMTOXINA (BOTOX) IN WOMEN WITH REFRACTORY OVERACTIVE BLADDER. FEMALE PELVIC MEDICINE <(>&<)> RECONSTRUCTIVE SURGERY. 2015;21(6):369-373. DOI: 10.1097/SPV.0000000000000200 SUMMARY: THE AIM OF THE STUDY WAS TO COMPARE THE SHORT-TERM OUTCOMES OF SACRAL NERVE STIMULATION (SNS) AND INTRADETRUSOR INJECTION OF ONABOTULINUMTOXINA (BOTOX) FOR OVERACTIVE BLADDER (OAB) SYMPTOMS REFRACTORY TO BEHAVIORAL MODIFICATIONS AND PHARMACOLOGIC THERAPY. THE SNS RESULTED IN LOWER FAILURE RATES AT 6 MONTHS WHEN PERFORMED FOR REFRACTORY OAB SYMPTOMS AS COMPARED WITH THE BOTOX PROCEDURE. HOWEVER, FURTHER STUDIES ARE NEEDED TO EVALUATE THE LONG-TERM COST EFFECTIVENESS OF BOTH PROCEDURES. REPORTED EVENTS: 1. 6 PATIENTS WITH SACRAL NERVE STIMULATION (SNS) FOR REFRACTORY OVERACTIVE BLADDER (OAB) EXPERIENCED AN INFECTION. AN UNKNOWN NUMBER OF THESE PATIENTS REQUIRED SURGERY FOR THIS COMPLICATION. 2. 3 PATIENTS WITH SNS FOR REFRACTORY OAB EXPERIENCED LEAD OR INS MALFUNCTION. AN UNKNOWN NUMBER OF THESE PATIENTS REQUIRED SURGERY FOR THIS COMPLICATION. 3. 2 PATIENTS WITH SNS FOR REFRACTORY OAB HAD THE DEVICE REMOVED DUE TO FAILURE. 4. 2 PATIENTS WITH SNS FOR REFRACTORY OAB EXPERIENCED WOUND SEROMA. AN UNKNOWN NUMBER OF THESE PATIENTS REQUIRED SURGERY FOR THIS COMPLICATION. 5. 5 PATIENTS WITH SNS FOR REFRACTORY OAB EXPERIENCED PAIN AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE. AN UNKNOWN NUMBER OF THESE PATIENTS REQUIRED SURGERY FOR THIS COMPLICATION. 6. 6 PATIENTS WITH SNS FOR REFRACTORY OAB EXPERIENCED STIMULATION DEPENDENT PAIN. AN UNKNOWN NUMBER OF THESE PATIENTS REQUIRED SURGERY FOR THIS COMPLICATION. 7. 1 PATIENT WITH SNS FOR REFRACTORY OAB HAD THE DEVICE REPOSITIONED. THE REASON FOR REPOSITIONING WAS NOT NOTED. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: INTERSTIM IMPLANTABLE NEUROSTIMULATOR (NO MODEL # PROVIDED) 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
    786918 INTERSTIM NEUROSTIMULATOR, UNKNOWN STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention