BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2895077 · Received January 3, 2013

    Report

    Report Number
    3004209178-2013-00098
    Event Type
    Injury
    Date Received
    January 3, 2013
    Report Date
    December 12, 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
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT # V021253, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS A POSSIBLE FALL. IT WAS NOTED THAT THERE WAS A LEAD BREAK. IT WAS UNCLEAR WHEN THE SYSTEM REPLACEMENT OCCURRED, AS PER INITIAL REPORTER AND MANUFACTURER REGISTRATION THE REPLACEMENT TOOK PLACE ON (B)(6)-2012, BUT PER PATIENT'S HEALTHCARE PROVIDER THE REPLACEMENT TOOK PLACE ON (B)(6)-2012. IT WAS REPORTED THAT HOSPITALIZATION WAS NOT REQUIRED AND THE REPLACEMENT WAS AN OUT-PATIENT PROCEDURE. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT RECEIVED A NEW SYSTEM AS HER IMPLANT DEPLETED AND LEADS HAD MIGRATED. ABOUT 4 MONTHS PRIOR TO THE REPORT, THE PATIENT NOTICED MORE BULGING AT THE LEAD SITE AND IT WAS SWOLLEN AND SORE. THE REPORTER INDICATED THAT THE PATIENT WAS INFORMED BY HER SURGEON THAT THE LEADS WERE "COMPLETELY DISCONNECTED." IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2520 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention