BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3863623 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11264
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    May 30, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 3889-28, LOT# VA0HZGL, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT THINKS SHE BROKE HER RIBS. SHE THINKS IT HAPPENED WHEN SHE WAS HAVING THE INTERSTIM IMPLANT SURGERY 3 WEEKS AGO. SHE BELIEVES WHEN HCPS (HEALTHCARE PROVIDER) MOVED HER FROM THE TABLE; THEY BROKE HER RIBS. THE PATIENT SAID SHE WAS FINE BEFORE SHE WENT IN FOR THE SURGERY. BUT AFTER SHE GOT HOME FROM THE SURGERY SHE STARTED FEELING PAIN. THE PATIENT MENTIONED IT TO HER HCP THE DAY BEFORE REPORTED EVENT DATE AND WILL HAVE X-RAYS DONE. COMPATIBILITY GUIDELINES WERE REQUESTED FOR THE X-RAY AND/OR FLUORO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338511 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention