BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2423331 · Received January 20, 2012

    Report

    Report Number
    3004209178-2012-00388
    Event Type
    Injury
    Date Received
    January 20, 2012
    Report Date
    January 3, 2012
    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

    LEAD MODEL 3889-28 LOT#V842735 IMPLANTED: (B)(6) 2011 EXPLANTED: (B)(6) 2011; PROGRAMMER MODEL 3037 SERIAL #(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM REMOVED ONE AND A HALF MONTHS POST IMPLANT DUE TO AN INFECTION. THE PATIENT HAD REPORTED TO THEIR PHYSICIAN SYMPTOMS OF PAIN IN THE LEGS AND SORENESS AROUND THE POCKET SITE. THEN IN THE LAST WEEK OF (B)(6) 2011, THE PATIENT REPORTED TO THEIR PHYSICIAN THAT THEY WERE IN A WHEELCHAIR AND COULD NOT WALK. THE PHYSICIAN WAS REFERRING THE PATIENT TO ADDITIONAL DOCTORS FOR FURTHER EVALUATIONS AND OPINIONS. FOLLOW-UP INFORMATION RECEIVED NOTED THAT THE PATIENT WAS IN A CAR ACCIDENT ABOUT ONE MONTH PRIOR TO IMPLANT AND DID NOT HAVE AN MRI OR CAT SCAN. THE PATIENT'S PHYSICIAN DID NOT BELIEVE THE ISSUES THE PATIENT WAS EXPERIENCING WAS RELATED TO THE INS. IF ADDITIONAL INFORMATION IS RECEIVED, 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention