BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 2624902 · Received June 21, 2012

    Report

    Report Number
    3004209178-2012-04729
    Event Type
    Malfunction
    Date Received
    June 21, 2012
    Report Date
    April 8, 2014
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). LEAD MODEL 3986A, LOT# N208353, IMPLANTED: 2009 (B)(6), EXPLANTED: NA; LEAD MODEL 3986A, LOT# N071535, IMPLANTED: 2009 (B)(6), EXPLANTED: NA; EXTENSION MODEL 748940, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), EXPLANTED: NA; PROGRAMMER MODEL 7434A, SERIAL# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT TURNS HIS STIMULATION OFF PRIOR TO DRIVING WHEN HE GOES OUT SHOPPING. HE DOES NOT CARRY HIS PROGRAMMER. STIMULATION TURNED ON WHILE HE WAS OPENING A FREEZER AT (B)(6). 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 THAT THE PATIENT OPENED THE FREEZER AND ¿THIS THING¿ STARTED COMING ON. IT WAS NOTED THAT THE PATIENT WAS AT (B)(4) AND IT TURNED ON.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS REFERRED TO A NEUROSURGEON FOR POSSIBLE REVISION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS AT WAL-MART IN THE FREEZER SECTION AND A FREEZER DOOR HIT HIM ON THE BUTT AS IT WAS CLOSING. IT WAS STATED THAT THIS CAUSED HIS THERAPY TO SHUT OFF.

    Description of Event or Problem · 1

    IT WAS REPORTED THE MAGNETIC REED SWITCH WAS ENABLED AND THE THERAPY WAS TURNING ON AND OFF WHEN THE PATIENT ENCOUNTERED EMI. IT WAS REPORTED THE MAGNETIC REED SWITCH WAS DISABLED AND THE THERAPY STOPPED TOGGLING ON AND OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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