BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2396236 · Received January 4, 2012

    Report

    Report Number
    3004209178-2012-00037
    Event Type
    Injury
    Date Received
    January 4, 2012
    Report Date
    December 13, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PROGRAMMER MODEL 3037, (B)(4), LEAD MODEL 3093-28, LOT# V841549, IMPLANTED: (B)(6) 2011.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS DOING WELL. THE PHYSICIAN BELIEVED THE SEIZURE WAS UNRELATED TO THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT TURNED OFF HER IMPLANTABLE NEUROSTIMULATOR (INS), ON (B)(6) 2011, BECAUSE HER LEGS FELT LIKE THEY W ERE ON FIRE. TWO DAYS LATER THE BURNING SENSATION HAD NOT RESIDED. ON (B)(6) 2011, THE PATIENT MET WITH HER SURGEON AND THE SURGEON STATED THAT THEY DID NOT BELIEVE THAT THE BURNING SENSATION IN THE LEGS WAS RELATED TO THE INS. WHILE IN HER SURGEON'S OFFICE, THE PATIENT HAD A SEIZURE AND WAS SENT TO THE ER. THIS WAS THE PATIENT'S FIRST SEIZURE. IT WAS NOTED THAT THE INS HAD BEEN OFF FOR 4 DAYS PRIOR TO THE SEIZURE. THE SURGEON COULD NOT DETERMINE THE SOURCE OF THE SEIZURES. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention