BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3881636 · Received June 18, 2014

    Report

    Report Number
    3007566237-2014-01698
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD FOUND THE DISTAL END OF THE LEAD WAS BENT (NEW OUT OF THE BOX). OTHER PARTS OF THE LEAD WERE ALSO BENT. THE CONTINUITY WAS ACCEPTABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE DOCTOR PULLED THE LEAD OUT OF THE PROTECTOR DURING THE PERIPHERAL NERVE EVALUATION, THE TIP WAS ¿BADLY¿ BENT. THE DOCTOR DID NOT USE THE LEAD AND ANOTHER LEAD WAS OPENED. NO SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358087 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3065USC N439249

    Patients

    Seq Age Sex Outcome Treatment
    1 00027 YR