BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 3021507 · Received March 26, 2013

    Report

    Report Number
    6000032-2013-00069
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    December 12, 2005
    Report Date
    March 27, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3487A, LOT # J0333642V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 748966, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL REVIEW DETERMINED THAT THE SHOCKING INVOLVING FLUID IN THE POCKET WAS A SEPARATE EVENT, AND WAS REPORTED UNDER MFR. REP. # 6000032-2013-00074. FOLLOW-UP REGARDING THE SUBSEQUENT SHOCKING IN LATE 2005 AND THE DEVICE FLIP WILL BE REPORTED UNDER THIS MFR. REP, # 6000032-2013-00069. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IN (B)(6) 2005 THE PATIENT WAS SITTING AT WORK AND ALL OF A SUDDEN STARTING GETTING SHOCKED AND JOLTED, HER TEETH WERE CHATTERING AND SHE COULDN'T GET HER STIMULATION TO TURN OFF. THE STIMULATION FINALLY TURNED OFF AFTER MULTIPLE ATTEMPTS AND THE PATIENT CALLED HER HCP AND WAS INSTRUCTED NOT TO TURN IT BACK ON AND TO GET AN X-RAY. THE PATIENT GOT AN X-RAY AND WAS TOLD THAT SOMETHING HAD MALFUNCTIONED AND SOMETHING WASN'T RIGHT WITH LEAD. THE PATIENT STATED THAT THE IPG WAS FLIPPED AND THE LEAD WAS TOO CLOSE TO THE SKIN AND COULD BE FELT. IT WAS NOTED THAT AT THE TIME THE PATIENT WAS WITHOUT STIMULATION AND WAS IN PAIN EVEN THOUGH HER HCP HAD PRESCRIBED MEDICATIONS.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT FELT A SHOCKING SENSATION FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS) OVER THEIR ENTIRE BODY. SPECIFICALLY, EVERY TIME THEY DECREASE THE STIMULATION WITH THE PROGRAMMER, IT CAUSED A "SURGE OF ELECTRICITY" THROUGHOUT THEIR BODY. IMPEDANCES MEASURED WERE IN THE RANGE OF 391 TO 535 OHM WITH THE EXCEPTION OF ELECTRODE COMBINATION OF #0 AND 3 WHICH WERE NOTED AT <(> <<)> 50 OHMS (SHORT). NO FALLS WERE REPORTED. THE CAUSE OF THE SHORT WAS UNKNOWN. FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL REPORTED THAT THEY HAD NO KNOWLEDGE OF THE EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SHOCKING THE PATIENT EXPERIENCED WAS DUE TO FLUID IN THE POCKET. THE PATIENT STATED THAT THEY HAD IF "FIXED" BUT NOTED THAT THEY SUBSEQUENTLY "FELT NODULES." TWO NURSES CONFIRMED THAT THE INS HAD FLIPPED BACKWARDS. IT WAS ALSO REPORTED THAT IN 2005 OR 2006, THE "UNIT" MALFUNCTIONED. SPECIFICALLY, IT WOULD TURN ON HIGH AND SHOCK THE PATIENT. THE PATIENT WAS TOLD THAT THEY NEEDED THE DEVICE REPLACED AND SUGGESTED THAT THEY TURN IT OFF. THE DEVICE WAS REPORTED TO HAVE BEEN REPLACED IN 2006. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123128 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7425

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Required Intervention