BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 1932089 · Received November 30, 2010

    Report

    Report Number
    6000032-2010-10037
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 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
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT HAD JUST HAD BACK SURGERY AND WAS IN THE HOSPITAL. THE PT HAD NO STIMULATION SENSATION ON THE RIGHT SIDE, BUT HAD STIMULATION FEELINGS ON THE LEFT SIDE. ALL THE STATUS LIGHTS CAME ON, ON THE PT PROGRAMMER, BUT HE WASN'T FEELING ANYTHING. IT WAS NOTED THAT THE PT'S DEVICES WERE REPORTED TO BE DUE FOR REPLACEMENT. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE. SEE ALSO MFR'S REPORT #6000032-2010-10038.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW MDT PUERTO RICO OPERATIONS CO, MED REL 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR IMPLANTED:| PROGRAMMER: MODEL 7434, LOT# YN0046941P| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7425,| LOT# NAT136931H| PROGRAMMER: MODEL 7434, LOT# YN0047674P| EXTENSION: MODEL 7496-66, LOT# YS0001615N| EXPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0085714N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3587A, LOT# L85959| IMPLANTED:| LEAD: MODEL 3986, LOT# NAM001582N