BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3920068 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-12672
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Report Date
    June 17, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 97754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 97740, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 39565-30, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3708160, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE, EXTENSION; PRODUCT ID 3708160, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IF THE PATIENT BENT OR TILTED SLIGHTLY THEIR STIMULATION WOULD GO OFF. THE PATIENT HAD ONE SETTING THAT THEY USED TO STAND AND 1 SETTING FOR WHEN THEY WENT TO BED. IF THE PATIENT BENT SLIGHTLY THEIR STIMULATION WOULD SWITCH TO THE LYING POSITION. THE PATIENT WANTED THEIR DEVICE REPROGRAMMED. THESE ISSUES STARTED A COUPLE OF WEEKS PRIOR TO THE REPORT. THE PATIENT HAD NOT HAD ANY FALLS OR TRAUMA. THE PATIENT HAD AN APPOINTMENT WITH THEIR DOCTOR THE WEEK AFTER THE REPORT. THE PATIENT SAW THEIR DOCTOR A MONTH PRIOR TO THE REPORT AND EVERYTHING WAS FINE THEN. IT WAS FURTHER REPORTED THAT THE DOCTOR WAS NOT AWARE OF ANY DEVICE PROBLEMS OR SYMPTOM CHANGES. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396744 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1