BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2070170 · Received April 25, 2011

    Report

    Report Number
    3007566237-2011-03081
    Event Type
    Injury
    Date Received
    April 25, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT UNDERWENT A SURGICAL PROCEDURE AND THE LEAD WAS REPLACED FOR AN UNK REASON. THE LEAD WORKED WITHOUT FURTHER PROBLEMS. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| STIM ACCESSORY: MODEL 3550-39, LOT# B0902605K| IMPLANTED:| LEAD: MODEL 3093, LOT# 0203450177| EXPLANTED:| EXPLANTED: