BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 3900681 · Received June 27, 2014

    Report

    Report Number
    6000032-2014-00131
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Report Date
    June 3, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3998, LOT# L56766, IMPLANTED: (B)(6) 1998, PRODUCT TYPE LEAD; PRODUCT ID 7434-E, SERIAL# (B)(4), IMPLANTED: (B)(6) 1998, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1998, PRODUCT TYPE EXTENSION; PRODUCT ID 7434-E, SERIAL# (B)(4), IMPLANTED: (B)(6) 1998, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT A MONTH AND 1/2 TO 2 MONTHS PRIOR TO THE REPORT, THE PATIENT FELT A QUICK JOLT WHEN HE ATTEMPTED TO TURN THE STIMULATOR UP/DOWN. THE STATUS LIGHTS WERE ASSESSED AND IT WAS NOTED THAT THE GREEN STATUS LIGHT NEXT TO THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY ICON WAS OFF. THE REPORTER NOTED THAT THE PATIENT HAD A LOW BATTERY AND IT EXPLAINED WHY THE PATIENT HAD BEEN IN PAIN LATELY. IT WAS NOTED THAT THE PAIN BEGAN ABOUT A MONTH PRIOR TO THE REPORT. THE REPORTER NOTED THAT THE PATIENT WAS HAVING PROBLEMS WITH THE PATIENT PROGRAMMER. IT WAS NOTED THAT THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION AND THE ISSUE BEGAN A COUPLE OF DAYS PRIOR TO THE REPORT. ON THE NIGHT PRIOR TO THE REPORT, THE PATIENT TRIED PRESSING BUTTONS AND NOTHING WOULD HAPPEN ¿ IT WOULDN¿T GO DOWN OR UP AND HE DIDN¿T HEAR ANY BEEPS OR ANYTHING. THE PATIENT CHANGED THE 9 VOLT BATTERY BUT IT DIDN¿T DO ANYTHING TO THE STIMULATOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378260 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 00046 YR