BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5363472 · Received January 13, 2016

    Report

    Report Number
    3004209178-2016-00442
    Event Type
    Injury
    Date Received
    January 13, 2016
    Report Date
    December 18, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER 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.

    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 (B)(6) TOTAL SINCE IMPLANT AND (B)(6) 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 PATIENT'S INDICATION FOR USE WAS URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR. NO OUTCOME AND INTERVENTIONS WERE PROVIDED WITH THIS EVENT. FURTHER FOLLOW UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF NEW INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23074 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention