BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 2992105 · Received March 7, 2013

    Report

    Report Number
    3004209178-2013-03418
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    February 19, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, NEU_UNKNOWN_EXT LOT#, SERIAL# (B)(4), PRODUCT TYPE EXTENSION PRODUCT ID, 7434A LOT#, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3587A LOT# L20853, IMPLANTED: 1992 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DID NOT GET GOOD THERAPY AND AN IMPLANTABLE NEUROSTIMULATOR WAS REVISED. IT WAS UNCLEAR IF THE REVISION WAS DUE TO THE LACK OF GOOD THERAPY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE WAS NORMALLY DEPLETED AT THE TIME OF REPLACEMENT. IT WAS STATED THE PLAN WAS TO 'NOT TOUCH' THE LEADS DURING THE REPLACEMENT. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97227 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 Required Intervention