BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTERSTIM II

    MDR report key: 2636056 · Received July 2, 2012

    Report

    Report Number
    3004209178-2012-05021
    Event Type
    Death
    Date Received
    July 2, 2012
    Date of Event
    April 30, 2012
    Report Date
    June 1, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28 LOT# V042808 SERIAL# IMPLANTED: (B)(6) 2007 EXPLANTED:; PRODUCT TYP LEAD PRODUCT ID 3037 LOT# SERIAL# (B)(4) IMPLANTED: (B)(6) 2007 EXPLANTED:; PRODUCT TYP PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT THE PATIENT WAS LAST SEEN IN THE PHYSICIAN'S OFFICE IN 2008. NO INFORMATION IN REGARDS TO HER DEATH WAS KNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT DIED (B)(6) 2012. THE CAUSE OF DEATH WAS AN INFECTED BLADDER AREA AND OTHER COMPLICATIONS STEMMING FROM THE INFECTION. IT WAS UNCLEAR IF THE CAUSE OF DEATH WAS DEVICE RELATED. IT WAS REPORTED THAT THE DEVICE HAD NEVER BEEN REPROGRAMMED OR ADJUSTED, AND THAT THE PATIENT HAD TO URINATE FREQUENTLY AT NIGHT. ADDITIONAL INFORMATION HAS BEEN 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 00085 YR Death| O