BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 3792444 · Received May 6, 2014

    Report

    Report Number
    3004209178-2014-08541
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    January 12, 2012
    Report Date
    April 10, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3093-33, LOT# V600262, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A LEAD MIGRATION FROM ORIGINAL X-RAY. NO ACTION HAD BEEN TAKEN AND THE EVENT WAS NOTED AS ONGOING. NO ADVERSE EVENT WAS NOTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENT WAS ONGOING. IT WAS NOTED THAT THE LEAD MIGRATED OUTWARD ON X-RAY COMPARISON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272813 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR