BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3023066 · Received March 27, 2013

    Report

    Report Number
    3004209178-2013-04287
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-33, LOT# VA00UVB, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED "PAIN IN HER BACK." IT WAS FURTHER REPORTED THAT THE PATIENT WAS "NOT SURE" IF IT WAS RELATED TO HER DEVICE AND THAT SHE HAD HAD THE BACK PAIN "SINCE 2009." THE PATIENT ALSO REPORTED THAT SHE WAS "STRUGGLING WITH HER THERAPY" AND THAT SHE EXPERIENCED LEAKAGE EPISODES IN ADDITION TO URINARY TRACT AND BLADDER INFECTIONS. THE PATIENT NOTED THAT SHE "HAD NEVER HAD A URINARY TRACT OR BLADDER INFECTION UNTIL SHE HAD HER DEVICE IMPLANTED." IT WAS STATED THAT THE PATIENT HAD HAD "NO FALLS OR TRAUMAS." AT THE TIME OF REPORT, THE PATIENT WAS SCHEDULED TO HAVE A MYELOGRAM AND X-RAY DONE TO AID IN HER BACK PAIN DIAGNOSIS. IT WAS ALSO REPORTED THAT THE PATIENT'S DEVICE WOULD "GET HUNG ON THINGS" WHEN THE PATIENT WAS SITTING DOWN. THE PATIENT REPORTED THAT SHE HAD LOST "A LOT OF WEIGHT" AND THAT HER DEVICE WAS "MORE PRONOUNCED." IT WAS NOTED THAT THE PATIENT FIRST NOTICED THIS OCCURRING "A LITTLE BEFORE (B)(6)" OF 2012. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY. ABOUT TWO WEEKS LATER, IT WAS REPORTED THAT THE URINARY TRACT INFECTION WAS UNRELATED TO THE INTERSTIM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126279 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention