BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 3073373 · Received April 23, 2013

    Report

    Report Number
    3007566237-2013-01408
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    April 10, 2013
    Manufacturer
    MDT SOFAMAR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7495-51, SERIAL # (B)(4), IMPLANTED: (B)(6) 1995, EXPLANTED: (B)(6) 1999; PRODUCT TYPE EXTENSION, PRODUCT ID 3888-28, LOT # L36800, IMPLANTED: (B)(6) 1995, EXPLANTED: (B)(6) 1999, PRODUCT TYPE LEAD.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE DID NOT HELP WITH PAIN, HOWEVER, IT MADE HIS LEG JUMP. THE INITIAL INCISION DID NOT HEAL PROPERLY AND THE PATIENT HAD MESH PUT IN. THE PATIENT HAD BEEN OPENED UP ON BOTH SIDES OF THE BODY AND STATED THAT HIS BODY WAS FULL OF MESH TO HOLD HIM TOGETHER. THE LEAD AND STIMULATOR WERE TAKEN OUT AT THE SAME TIME SCREWS WERE REMOVED FROM HIS SPINE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD A COMPLETE EXPLANT OF HIS IMPLANTABLE NEUROSTIMULATOR (INS) AND COMPONENTS. IT WAS NOTED THAT THE PATIENT WAS "HEADED TO" BEING PARALYZED SINCE THE LEADS WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173565 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMAR DANEK PUERTO RICO MFG 7425

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention