BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 6755418 · Received July 31, 2017

    Report

    Report Number
    3004209178-2017-15940
    Event Type
    Injury
    Date Received
    July 31, 2017
    Date of Event
    October 1, 2015
    Report Date
    July 31, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    UDI-DI
    00613994287731
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28 ,LOT# V052586, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THE CALLER REPORTED THE PATIENT WAS SCHEDULED FOR AN MRI OF THEIR KNEE. IT WAS REPORTED THE PATIENT HAD THEIR DEVICE EXPLANTED, BUT WHEN THE PHYSICIAN ATTEMPTED TO EXPLANT THE LEAD, SOME OF THE ELECTRODE WERE BROKEN OFF AND LEFT IN THE PATIENT'S BODY. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534100 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023 00613994287731

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention