BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2831345 · Received November 14, 2012

    Report

    Report Number
    3004209178-2012-10229
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    November 14, 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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V794135, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE A POST OPERATIONAL INFECTION OR MENINGITIS. A CULTURE WAS NOT OBTAINED. THE PATIENT WAS SEEN FOR REPROGRAMMING (B)(6)-2012. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND HAD INFECTIONS. THE PATIENT STATED SHE HAD A RETURN IN SYMPTOMS AND THAT SHE HAD "INFECTIONS A LOT" WHICH HAD "THROWN HER THERAPY OFF." THE PATIENT ALSO SAID IT WAS HARD TO TELL WHEN THE SYMPTOMS RETURNED BECAUSE SHE "GOT INFECTIONS A LOT." IT WAS UNCLEAR IF THE PATIENT HAD AN INFECTION THOUGH BECAUSE SHE ALSO STATED THAT SHE WAS "NOT SURE" IF SHE HAD AN "INFECTION OR NOT." ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other