BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5723583 · Received June 14, 2016

    Report

    Report Number
    3004209178-2016-12124
    Event Type
    Injury
    Date Received
    June 14, 2016
    Date of Event
    April 20, 2015
    Report Date
    June 14, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-33, LOT#: V963187, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD . A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER REPORTED THAT A PATIENT HAD AN IMPLANTABLE NEUROSTIMULATOR (INS) AND ELECTRODE REMOVED ON (B)(6) 2015 AND STATED IT WAS "NON FUNCTIONING". THERE WERE NO PATIENT SYMPTOMS REPORTED. THE INS WAS INDICATED FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION/GASTROINTESTINAL/PELVIC FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377812 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention