BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 3851169 · Received June 5, 2014

    Report

    Report Number
    6000032-2014-00111
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 3487A, LOT# L73153, IMPLANTED: (B)(6) 1999, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A LOSS OF STIMULATION/THERAPEUTIC EFFECT. THE PATIENT EXPERIENCED LESS THAN 50% THERAPY RELIEF. THE PATIENT¿S ORIGINAL PAIN RETURNED TO HIS UPPER BACK WITH THE LOSS OF STIMULATION. IT WAS REPORTED THE PATIENT HAD NOT HAD STIM FOR ¿QUITE SOME TIME¿ AND WAS UNSURE HOW LONG. THE PATIENT REPORTEDLY HAD A SIGNIFICANT FALL 1-2 YEARS AGO THAT MAY COINCIDE WITH THE LOSS OF STIMULATION. IT WAS NOTED THE FALL INVOLVED IMPACT TO THE PATIENT¿S UPPER AND MID-BACK. THE STIM WAS UNABLE TO BE FELT AT ANY AMPLITUDE THE DAY OF THE CURRENT REPORT. IT WAS REPORTED THERE WERE HIGH IMPEDANCES GREATER THAN 40,000 OHMS. IT WAS NOTED THE PATIENT WANTED A LEAD REPLACEMENT AND AN UPDATE WAS GIVEN TO THE PATIENT¿S CURRENT MANAGING PHYSICIAN. THERE WAS NO DATE SET. NO DIAGNOSTIC TESTING WAS PERFORMED OR PLANNED. THE PATIENT¿S STATUS WAS NOTED TO BE ALIVE WITH NO INJURY. IT WAS NOTED THAT THERE WAS NO FUTURE CONTACT PLANNED WITH THE PATIENT BY THE REP WHO MET WITH THE PATIENT THE DAY OF THE CURRENT REPORT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT ALMOST ALL ELECTRODE PAIRS WHEN TESTED AT 1.5 VOLTS WERE GREATER THAN 4000 OHMS. ELECTRODE PAIR 0 <(>&<)>1 READ ¿???¿ ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AT THE TIME OF INITIAL REPORT. A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329921 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