BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3052063 · Received April 11, 2013

    Report

    Report Number
    3004209178-2013-05989
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 22, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANT SHOWED A POWER ON RESET (POR) CONDITION DURING OR AFTER ASURGICAL REVISION. IT WAS REPORTEDLY RELATED TO ELECTROMAGNETIC INTERFERENCE (EMI) AND THE HEALTH CARE PROVIDER (HCP) WAS ASSISTED IN CLEARING THE POR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156718 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1