BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3964557 · Received July 29, 2014

    Report

    Report Number
    3004209178-2014-13628
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 8, 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

    PRODUCT ID 97740, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 97754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE PATIENT STILL FELT STIMULATION BUT THERAPY STOPPED HELPING TO COVER THE PAIN ON SATURDAY. IT WAS NOTED THAT THE SYMPTOMS REPORTED HAD A SUDDEN ONSET. THE PATIENT CALLED TO REQUEST A MANUFACTURER REPRESENTATIVE TO BE AT THEIR APPOINTMENT WITH THE HEALTHCARE PROFESSIONAL (HCP) 2014 (B)(6) FOR A PROGRAMMING ADJUSTMENT. THE PATIENT ASKED FOR HELP WITH REPROGRAMMING. THE PATIENT WAS REDIRECTED TO THE HEALTHCARE PROFESSIONAL (HCP). ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440940 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1