BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2897189 · Received January 4, 2013

    Report

    Report Number
    3004209178-2013-00159
    Event Type
    Injury
    Date Received
    January 4, 2013
    Report Date
    December 13, 2012
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-33, LOT # V851923, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A "MASS IN THEIR PELVIS." IT WAS UNCLEAR IF THIS WAS A DEVICE RELATED EVENT. IT WAS NOTED THE PATIENT HAD THEIR STIMULATION TURNED UP HIGH, BUT HAD TO DECREASE IT RECENTLY TO MAKE IT "MORE COMFORTABLE." ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT STILL HAD CONCERNS WHEN THEY HAVE MEDICAL TESTS OR DENTAL WORK DONE. THE PATIENT RECEIVED ASSISTANCE FROM THE MANUFACTURING REPRESENTATIVE AND HAD SOME CONCERNS RESOLVED. HOWEVER, IT WAS ALSO STATED THE PATIENT CONTINUED TO HAVE SOME CONCERNS REGARDING THE DEVICE AND HAD A SCHEDULED DOCTOR APPOINTMENT ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4086 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention