BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5094699 · Received September 22, 2015

    Report

    Report Number
    3004209178-2015-18427
    Event Type
    Injury
    Date Received
    September 22, 2015
    Report Date
    August 28, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 093-28 ,LOT# V850461, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4)

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THERE WAS A REVISION TO REPOSITION THE DEVICE IN (B)(6) 2012. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPOSITIONED BECAUSE OF WHERE THE INS WAS ON THE BACK AND IT WAS IRRITATING. THERE WAS ALSO SWELLING AT THE INS SITE. THEY MOVED IT OVER A LITTLE BIT AND OVER THE HIP ON THE LEFT SIDE. SHE HAD NO MORE IRRITATION SINCE THEY MOVED THE DEVICE AND SHE RECOVERED COMPLETELY. IT WAS NOTED THAT THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDES GASTROINTESTINAL/PELVIC FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626364 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention