BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3182997 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10730
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    June 2, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3 889-28, LOT# V598061, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE EVENT RESOLVED WITHOUT OUTCOME ON (B)(6), 2013. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELT ¿VERY FATIGUED¿. THE PATIENT WAS ADMINISTERED A VITAMIN B 12 INJECTION. THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2013. IT WAS LATER REPORTED THAT THE INJECTIONS WERE ADMINISTERED ON (B)(6) 2012. THE EVENT RESOLVED WITHOUT SEQ UELAE ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283641 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention