BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 2875316 · Received December 17, 2012

    Report

    Report Number
    3004209178-2012-11896
    Event Type
    Injury
    Date Received
    December 17, 2012
    Report Date
    November 27, 2012
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 7495-51 LOT# SERIAL# (B)(4), PRODUCT TYPE EXTENSION PRODUCT ID, 7434A LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3888-33 LOT# L60114, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THERE WAS NORMAL BATTERY DEPLETION. IT WAS NOTED THE PATIENT PLANNED TO SEE THEIR HEALTH CARE PROVIDER TO TALK ABOUT REPLACING THE IMPLANTABLE NEUROSTIMULATOR (INS). APPROXIMATELY ONE MONTH LATER, IT WAS REPORTED, IT WAS TIME TO HAVE THE INS REPLACED. IT WAS NOTED, THE DEVICE WOULD "CLICK ON AND OFF" AT TIMES AND THAT IS WHY THEY BELIEVED THEY NEEDED IT REPLACED. IT WAS ALSO NOTED THE INS WOULD "SHOCK THE PATIENT ALL OF A SUDDEN." WHEN CLARIFIED IT WAS NOTED, THE INS DOES NOT "SHOCK" BUT IT TURNS ON AND OFF BY ITSELF AT TIMES. ONE WEEK LATER, IT WAS REPORTED THERE WAS A SHOCKING AND JOLTING SENSATION AND THAT STIMULATION WAS INTERMITTENT. IT WAS ALSO NOTED, THE STIMULATION TURNED ON AND OFF INTERMITTENTLY. PATIENT FELT SHOCKING IN THEIR NECK, INTO THEIR HEAD AND ARMS, AND SOMETIMES DOWN THEIR LEG. THERE WAS NO REPORTED FALL OR TRAUMA. THE PROBLEM STARTED APPROXIMATELY ONE YEAR PRIOR. IMPEDANCES WERE CHECKED AND INDICATED A POSSIBLE CONNECTION ISSUE. FOLLOW UP REPORTED, THE INS AND EXTENSION WOULD BE REPLACED IN (B)(6). THERAPY WAS NOT CURRENTLY EFFECTIVE DUE TO SHOCKING AND JOLTING WHEN TURNED ON.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THAT THE PATIENT HAD THEIR IMPLANTABLE NEUROSTIMULATOR EXPLANTED. IT WAS ALSO NOTED THE PHYSICIAN WAS NOT WILLING TO REVISE OR REPLACE THE LEAD SINCE IT WAS A CERVICAL LEAD. THE PATIENT WAS REPORTED TO HAVE BEEN "RECEIVING EFFECTIVE THERAPY FOLLOWING THE REPLACEMENT". IT WAS NOTED THAT THERE WAS "ONE ELECTRODE THAT WAS OUT OF RANGE DURING THE IMPEDANCE TEST". IT WAS ADDITIONALLY NOTED THAT THE PATIENT RECEIVED "GOOD COVERAGE" AFTER THE OUT OF RANGE ELECTRODE WAS PROGRAMMED AROUND.

    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 Required Intervention