BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3142534 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08537
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 13, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28 LOT# VA006QT, IMPLANTED: 2012 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    UPON FURTHER REVIEW PATIENT CODE DOES APPLY.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT¿S OVERACTIVE BLADDER SYMPTOMS RETURNED AND THEY WANTED THE DEVICE REMOVED. THE DEVICE WAS REMOVED AS OF THE DATE OF THIS REPORT. THE PATIENT OUTCOME WAS NOT PROVIDED. 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 CAUSE OF THE EVENT WAS DEVICE EROSION. AN INFECTION WAS ALSO NOTED. HOSPITALIZATION WAS REQUIRED. THE PATIENT OUTCOME WAS INDICATED AS SERIOUS INJURY/ILLNESS AND ONGOING. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243738 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R