BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3190598 · Received June 26, 2013

    Report

    Report Number
    9614453-2013-01448
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    April 15, 2005
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 30802836, LOT # B0245895K, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD; PRODUCT ID 30951036, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 30802836 LOT# B0245895K, IMPLANTED: 2004 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 30951036 LOT# SERIAL# (B)(4), IMPLANTED: 2004 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFECTION AT PLACE OF IMPLANT. THE PATIENT RECEIVED ANTIBIOTIC THERAPY AMOX-CLAVULAN ZURN. IT WAS ALSO REPORTED THAT THERE WAS BAD EROSION THROUGH SKIN, LEAD EROSION. NO IPG INFECTION. THE ISSUE WAS NOTED AS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291320 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW IPG MFG SWITZERLAND 302336

    Patients

    Seq Age Sex Outcome Treatment
    1 00025 YR Required Intervention