BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3215895 · Received July 10, 2013

    Report

    Report Number
    3004209178-2013-11548
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    April 6, 2011
    Report Date
    January 17, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3093-28 LOT# V641092, IMPLANTED: 2011 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT EXPERIENCED PAIN, REDNESS, AND WARM TO THE TOUCH AT THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET SITE 2 WEEKS STATUS POST IMPLANTATION. THE PATIENT WAS GIVEN CEFTIN (500 MG, Q 12 HRS FOR 10 DAYS). FOURTEEN DAYS LATER, IT WAS REPORTED THAT THE PATIENT HAD RECOVERED WITHOUT SEQUELAE WITH THE RESOLVED DATE OF (B)(6) 2011 NOTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE PATIENT WAS GIVEN CEFTIN PROPHYLACTICALLY. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319258 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention