BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2690208 · Received August 10, 2012

    Report

    Report Number
    3004209178-2012-06721
    Event Type
    Injury
    Date Received
    August 10, 2012
    Report Date
    July 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V841549, SERIAL#, IMPLANTED: 2011 (B)(6), EXPLANTED: PRODUCT TYPE LEAD, PRODUCT ID 3037, LOT#, SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS STARTING TO HAVE "ACCIDENTS AT NIGHT". IT WAS NOTED THAT THE PATIENT HAD "GREAT SUCCESS WITH THE DEVICE IN THE BEGINNING". IT WAS FURTHER NOTED THAT THE PATIENT HAD A SERIES OF STROKES, THE LAST BEING 3 WEEKS AGO. IT WAS STATED THAT THE PHYSICIANS DID NOT KNOW WHY THE PATIENT WAS HAVING STROKES, AND THAT SHE HAD 4 OR 5 MAJOR STROKES. THE PATIENT OUTCOME WAS NOT PROVIDED. 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