BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 5563547 · Received April 8, 2016

    Report

    Report Number
    3004209178-2016-07088
    Event Type
    Injury
    Date Received
    April 8, 2016
    Date of Event
    February 22, 2008
    Report Date
    April 8, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3487A-33, LOT# V042098, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THEIR CABLE BROKE SO THEY HAD TO HAVE THE DEVICE REPAIRED. MEDICAL RECORDS WERE OBTAINED AND A PROCEDURE WAS NOTED ON (B)(6) 2008. THE PROCEDURE WAS DUE TO A MALFUNCTIONING DORSAL COLUMN STIMULATOR AND A LEAD REVISION WAS PERFORMED. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM AND GENERAL ANESTHESIA WAS ADMINISTERED. THE LEAD-EXTENSION CONNECTION WAS IDENTIFIED USING FLUOROSCOPY AND THAT AREA WAS ANESTHETIZED. THE SKIN WAS INCISED AND THE CONNECTION WAS EXTERNALIZED. THE LEAD WAS THEN DISCONNECTED AND THE ANCHOR WAS FOUND AND FREED FROM THE SUTURES. THE EXISTING LEAD WAS PULLED OUT WITHOUT ANY DIFFICULTY AND THE TIP WAS INTACT. AN EPIDURAL NEEDLE WAS INSERTED INTO THE EPIDURAL SPACE AT THE T12-L1 LEVEL AND A NEW LEAD WAS IMPLANTED. THE LEAD WAS ADVANCED TO THE LEFT OF MIDLINE UNTIL ELECTRODE 0 WAS AT THE T8 LEVEL. THE PATIENT WAS IMPLANTED FOR LUMBAR RADICULOPATHY AND SPINAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217460 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7425

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention