BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 5718220 · Received June 10, 2016

    Report

    Report Number
    3004209178-2016-11973
    Event Type
    Injury
    Date Received
    June 10, 2016
    Report Date
    June 10, 2016
    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
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3889-28, LOT# V000764, IMPLANTED: (B)(6) 2006. THIS DEVICE IS INCLUDED IN THE MEDICAL DEVICE CORRECTION, "UNRETRIEVED DEVICE FRAGMENTS MODELS 3093 AND 3889 INTERSTIM TINED LEA DS", EDUCATIONAL BRIEF/PHYSICIAN COMMUNICATION (B)(6) 2010).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX, DATE OF BIRTH. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE HEALTHCARE PROVIDER (HCP), A MRI TECH, REPORTED THAT THE SYSTEM WAS RECENTLY REMOVED, BUT PART OF THE LEAD HAD GROWN INTO THE BONE AND WAS UNABLE TO BE REMOVED. THE HCP DID NOT KNOW HOW LONG THE LEAD FRAGMENT WAS OR WHY THE SYSTEM WAS REMOVED. THE HCP DID NOT KNOW WHEN THE SYSTEM WAS REMOVED, BUT STATED IT WAS RECENT BECAUSE THE PATIENT STILL HAD STITCHES. THE PATIENT'S INDICATION(S) FOR USE WERE URINARY DYSFUNCTION AND SACRAL NERVE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372970 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention