BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 5440971 · Received February 17, 2016

    Report

    Report Number
    6000153-2016-00480
    Event Type
    Injury
    Date Received
    February 17, 2016
    Date of Event
    May 1, 2014
    Report Date
    January 25, 2016
    Manufacturer
    NEURO - VILLALBA
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER REPORTED SHE SUDDENLY HAD OCCASIONAL URGENCY THAT LASTED ABOUT HALF A DAY EVERY TWO MONTHS. THIS HAD OCCURRED 4-5 TIMES SINCE IMPLANT. IT WAS NOTED THE PATIENT HAD NOT FALLEN OR HAD TRAUMA. THE PATIENT HAD LOST ABOUT 40 POUNDS TOTAL SINCE IMPLANT AND 25 POUNDS MOST RECENTLY, WHICH HAD CAUSED THE IMPLANTABLE NEUROSTIMULATOR (INS) TO MOVE OUT OF THE FAT POCKET. IT WAS SITTING RIGHT UNDER THE SKIN. INTERVENTIONS INVOLVED THE PATIENT INFORMING HER PHYSICIAN REGARDING THE SYMPTOMS OF URGENCY, BUT NOT THE WEIGHT LOSS/INS ISSUE. THE PATIENT HAD TAKEN AZO PILLS TO NUMB THE INSIDE AFTER THE URGENCY. THE FOLLOWING DAY, IT HAD RESOLVED. THE PATIENT HAD NOT CHANGED THE SETTINGS TO HER IMPLANT. THE CONSUMER FURTHER REPORTED THAT THE CIRCUMSTANCES THAT LED TO THE PATIENT'S OCCASIONAL URGENCY ISSUES SINCE IMPLANT WERE UNKNOWN. THE HEALTH CARE PROVIDER (HCP) DIDN'T KNOW AND IT HAPPENED EVERY 4 TO 6 WEEKS. THE STEP TAKEN TO RESOLVE THE URGENCY ISSUES AND THE STIMULATOR MOVING WAS THAT THE PATIENT HAD REVISION SURGERY TO THE LEAD AND GENERATOR. THE PATIENT'S INDICATION FOR USE WAS URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98075 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW NEURO - VILLALBA 3093-28 VA0GV3W

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Required Intervention