BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL II

    MDR report key: 1962846 · Received January 13, 2011

    Report

    Report Number
    6000032-2011-00364
    Event Type
    Injury
    Date Received
    January 13, 2011
    Report Date
    December 30, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., MED REL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT FELT BURNING PAIN OVER THE IPG SITE IN HIS ABDOMEN. THERE WAS A WELT APPROXIMATELY TWO INCHES IN DIAMETER OVER THE IPG. REPROGRAMMING DID NOT ALLEVIATE THE BURNING SENSATION. IMPEDANCES WERE IN THE 100'S. THE DEVICE WAS TURNED OFF AND THE PAIN CONTINUED ALONG WITH AN INCREASE IN THE REDNESS OVER THE IPG. IT WAS LATER STATED THAT THE DEVICE HAD "SHORTED OUT AND STOPPED WORKING" AND WAS REMOVED. THE LEADS REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL II LGW MDT PUERTO RICO OPERATIONS CO., MED REL 7424 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention