BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4113529 · Received September 24, 2014

    Report

    Report Number
    3004209178-2014-17617
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    June 10, 2014
    Report Date
    September 3, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA0HP78, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A WOUND INFECTION AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE AFTER A DEVICE REPLACEMENT ON (B)(6) 2014. THE DOCTOR PRESCRIBED ANTIBIOTICS AND IT TOOK A WHILE, BUT THE PATIENT FINALLY HEALED UP. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE INFECTION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. SEE MFR. REPORT # 3004209178-2014-09895 FOR INFORMATION REGARDING THE DEVICE REPLACEMENT PRIOR TO THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595554 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention