BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 1915537 · Received November 5, 2010

    Report

    Report Number
    6000032-2010-08976
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 16, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SEE ALSO MANUFACTURER REPORT #3004209178-2010-08974. IT WAS REPORTED THAT WHILE THE STIMULATION WAS TURNED ON, THE PT STATED THAT ONE OF THE WIRES WAS "SHORTING OUT." NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE PROVIDED. ADDITIONAL INFO WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A FOLLOW-UP WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 51 YR IMPLANTABLE NEURO STIMULATOR: MODEL 7427,| EXPLANTED:| EXTENSION: MODEL 7495-66, LOT# XS0005198N| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3998, LOT# L83338| IMPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0063737N| IMPLANTED:| EXTENSION: MODEL 7495-66, LOT# XS0005956N| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3587A, LOT# L61186A| EXPLANTED:| IMPLANTED:| LOT# NFE143119H| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT006354P| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7434, LOT# YN0032422P