BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5847158 · Received August 4, 2016

    Report

    Report Number
    3004209178-2016-15566
    Event Type
    Injury
    Date Received
    August 4, 2016
    Report Date
    August 4, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUXCS: PRODUCT ID 3889-28, LOT# V142238, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2012, 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

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT IMPLANTED FOR URINARY DYSFUNCTION; BOWEL DYSFUNCTION; FECAL INCONTINENCE; AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED IMPLANTABLE NEUROSTIMULATOR WAS REMOVED AND REPLACED BECAUSE IT ¿WASN¿T FUNCTIONING.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498212 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention