BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3896862 · Received June 26, 2014

    Report

    Report Number
    3004209178-2014-12082
    Event Type
    Injury
    Date Received
    June 26, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# VA06P0G, IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD PAIN AROUND THE IMPLANT SITE. IT WAS NOTED, THE PAIN STARTED FOUR DAYS PRIOR TO REPORT. IT WAS REPORTED SHUTTING THE DEVICE OFF DID NOT RESOLVE THE ISSUE. ADDITIONAL INFORMATION RECEIVED LATER INDICATED THAT THE PATIENT STILL HAD SOME DISCOMFORT AT IMPLANT SITE. THE HEALTHCARE PROVIDER WAS DOING A REVISION OF THE POCKET ON (B)(6). IT WAS REPORTED THAT 10 DAYS LATER, THE PATIENT HAD HER REVISION ON (B)(6). THE PATIENT PAIN WAS GONE AND SHE WAS DOING WELL. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374333 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Required Intervention