BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1831830 · Received September 8, 2010

    Report

    Report Number
    3007566237-2010-06856
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 5, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEAD HAD MIGRATED WHICH WAS CONFIRMED BY THE HEALTHCARE PROFESSIONAL. SHE HAD SURGERY SCHEDULED TO RE-POSITION THE LEAD. UNABLE TO FOLLOW UP WITH THE CONTACT INFORMATION PROVIDED, HENCE NO ADDITIONAL INFORMATION WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MEDTRONIC NEUROMODULATION 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| EXPLANTED:| LEAD: MODEL #LEAD URO, LOT #UNK