BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN NEUROSTIMULATOR

    MDR report key: 3103004 · Received May 9, 2013

    Report

    Report Number
    3007566237-2013-01569
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 16, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD. PRODUCT TYPE: LEAD: PRODUCT ID NEU_PTM_PROG. PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT CONTACTED TECHNICAL SUPPORT BEFORE BEING SEEN BY THE MANUFACTURER REPRESENTATIVE. IT WAS STATED THAT IT TURNED OUT THAT THE PATIENT NEEDED TO SIMPLY RECHARGE THE BATTERY. IMPEDANCE MEASUREMENTS WERE REPORTEDLY WITHIN NORMAL LIMITS. IT WAS ALSO STATED THAT THE PATIENT HAD A CT DONE FOR OTHER REASONS; NO X-RAYS WERE TAKEN. IT WAS FURTHER STATED THAT THE PATIENT WAS REPROGRAMMED, THE SENSOR WAS ORIENTED, AND THE PATIENT WAS EDUCATED ABOUT THE PATIENT PROGRAMMER AND THE RECHARGER. NO MALFUNCTIONS WERE SEEN. IT WAS ADDED THAT THE PATIENT NOW HAD GOOD STIMULATION AND WAS DOING WELL. COMPLETED COVERAGE WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN ULTRASOUND DONE OF THE KIDNEY ((B)(6) 2013) AND THE DEVICE HAD NOT WORKED EVER SINCE. IT WAS STATED THAT DURING THE PROCEDURE, THE ULTRASOUND WAS RIGHT OVER THE IMPLANT AND THAT "IT HURT." IT WAS ALSO STATED THAT THIS WAS THE START OF THE RECHARGING ISSUE AND THE PATIENT LOST THERAPY BECAUSE THEY COULD NOT RECHARGE. THE MANUFACTURER REPRESENTATIVE HAD TRIED TO CALL THE PATIENT BACK FOR TROUBLESHOOTING. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD NOT BEEN SEEN YET. THE CAUSE OF THE ISSUE WAS YET TO BE DETERMINED. THE PATIENT WAS STILL UNABLE TO RECHARGE. ADDITIONAL INFORMATION HAD BEEN REQUESTED, BUT WAS UNAVAILABLE AT THE DATE OF THIS REPORT. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203219 UNKNOWN NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1