BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2950030 · Received February 8, 2013

    Report

    Report Number
    3004209178-2013-01471
    Event Type
    Injury
    Date Received
    February 8, 2013
    Report Date
    January 14, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3889-28 LOT# V534733, IMPLANTED: 2010 (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

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

    Description of Event or Problem · 1

    FURTHER EVALUATION OF THIS EVENT DETERMINED THAT THIS EVENT HAD BEEN PREVIOUSLY REPORTED IN MANUFACTURERS REPORT #3004209178-2013-03753. ALL FURTHER FOLLOW UP INFORMATION WILL BE REPORTED IN UNDER THIS CURRENT MANUFACTURERS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE X-RAYS SHOWED NO EVIDENCE OF ABNORMALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAS HAD PAIN AT THE POCKET SITE AS WELL AS LACK OF EFFECT FROM THE IMPLANTABLE NEUROSTIMULATOR (INS). NUMEROUS PROGRAMMING CHANGES WERE DONE, NONE OF WHICH IMPROVED PATIENT SYMPTOMS. THE INS WAS EXPLANTED. THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54885 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention