BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 3093506 · Received May 6, 2013

    Report

    Report Number
    6000032-2013-00114
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Report Date
    May 22, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7434-E, SERIAL# (B)(4), IMPLANTED: (B)(6) 1997. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1997. PRODUCT TYPE: EXTENSION: PRODUCT ID 3888-28, LOT# L44897, IMPLANTED: (B)(6) 1997. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED STARTING ABOUT SIX MONTHS PRIOR THE PATIENT'S STIMULATOR HAD BEEN TURNING ON RANDOMLY BY ITSELF. IT WAS NOTED THE PATIENT THOUGHT IT OCCURRED APPROXIMATELY A COUPLE TIMES A MONTH. 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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT SAW HER DOCTOR ON (B)(6), 2013, AND HER DOCTOR CONFIRMED THERE WAS NOTHING WRONG WITH HER IMPLANTABLE NEUROSTIMULATOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT WHEN THE PATIENT GOT OUT OF HER CAR AND STOOD UP HER DEVICE TURNED ON. THE PATIENT NOTED THAT SHE COULD BE ¿STANDING UP HERE IN THE KITCHEN AND IT¿LL HOP ON.¿ THE PATIENT NOTED SHE HAD THE DEVICE OFF WHEN SHE WALKED OR DROVE BECAUSE SHE COULD NOT PERFORM THOSE FUNCTIONS WITH THE DEVICE ON. THE PATIENT HAD THE DEVICE ON WHEN SHE SLEPT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT REPROGRAMMING WAS DONE SUCCESSFULLY. THERE WERE NO MALFUNCTIONS SEEN AND THE CAUSE OF THE EVENT WAS NOT DETERMINED. NO INTERVENTIONS WERE PERFORMED. THE PATIENT WAS REPORTEDLY FINE AND RECEIVING THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196676 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