BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3214041 · Received July 9, 2013

    Report

    Report Number
    3004209178-2013-11505
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    January 26, 2011
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT# J0546695V, IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3031A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S LEAD WAS DAMAGED DURING THE EXPLANT PROCEDURE AND WAS LEFT IN THE LEFT BUTTOCK AREA. THE LENGTH OF THE LEAD WAS UNKNOWN AND IT WAS ABANDONED BECAUSE IT BROKE DURING EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313132 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR Other