BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4295031 · Received December 3, 2014

    Report

    Report Number
    3004209178-2014-22506
    Event Type
    Malfunction
    Date Received
    December 3, 2014
    Report Date
    November 10, 2014
    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 Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377775, LOT# V003642, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 3888-56, LOT# V010760, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 3888-56, LOT# V009997, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT MOVED INTO CERTAIN POSITIONS SUCH AS CROSSING OF THE LEGS, LOOKING UP AT THE SKY OR ¿BACK AT¿ SHE WOULD GET A SUDDEN SURGE OF STIMULATION (OVERSTIMULATION SENSATION) AND THE PATIENT WOULD FEEL HER PAIN RETURN AND THEN IT WOULD TURN OFF. WHEN THE PATIENT INTERROGATED THE DEVICE THE SCS SYSTEM WAS OFF AND IT WOULD SHOW AS DISCHARGED/DEPLETED. THIS ISSUE HAD BEEN HAPPENING FREQUENTLY WITH POSITIONAL CHANGING AND HAD BEEN AN ISSUE SINCE THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED. THE PATIENT WENT FROM A LARGER TO SMALLER INS. THERE WAS A SUDDEN LOSS OF STIMULATION AND THERAPEUTIC EFFECT. THE PATIENT ALSO COMPLAINED OF SHARP PAIN/DISCOMFORT AT THE INS SITE WITH STIMULATION ON OR OFF. THE ADAPTIVE STIMULATION WAS DEACTIVATED AND THE PATIENT WAS ADVISED TO USER HER THERAPY MANUALLY AS WITH HER PRIOR SYSTEM. THERE WERE FOUR PROGRAMS RUNNING. HOWEVER, THE PATIENT WAS ADVISED TO WORK WITH EACH PROGRAM INDEPENDENTLY TO SEE IF ALL FOUR NEEDED TO BE RUNNING. THE PATIENT¿S INS WAS AT 3.7 WHEN THE CALLER VISITED WITH THE PATIENT. THE PATIENT MENTIONED SHE HAD TWO PROGRAMS WITH HER PRIOR DEVICE. THERE WAS AN IMPEDANCE CHECK WHICH WAS IN A NORMAL RANGE. THE EVENT OCCURRED DURING NORMAL USE. THERE WERE NO INFECTION CONCERNS AND NO FALLS RELATED TO ISSUES. THE CAUSE OF EVENT WAS NOT DETERMINED. IT WAS NOT KNOWN IF IT WAS DEVICE RELATED. THERE WAS NO REPROGRAMMING NEEDED. THE PATIENT¿S STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY. THE PATIENT WAS STABLE AND RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780435 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR