BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3191427 · Received June 26, 2013

    Report

    Report Number
    9614453-2013-01452
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    February 10, 2006
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 309328, LOT# B0414493K, IMPLANTED: 2006-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 30951036, SERIAL# (B)(4), IMPLANTED: 2006-(B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD. PRODUCT ID: 309510, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: EXTENSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A WOUND INFECTION THAT WAS NOT CLINICALLY PROVEN. THE PATIENT WAS GIVEN FLUCLOXACILLIN. IT WAS NOTED THAT THIS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290928 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW IPG MFG SWITZERLAND 302336

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention