BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2990145 · Received March 5, 2013

    Report

    Report Number
    3004209178-2013-03330
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 15, 2013
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 399930, LOT# V173396, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID 399930, LOT# J0546605V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID 3550-29, LOT# N267539, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING AND INTERMITTENT SURGING SENSATIONS AFTER EXPOSURE TO SOME RAILROAD TRACKS. SPECIFICALLY, THE PATIENT WAS RETURNING HOME AFTER A REPROGRAMING SESSION WHEN THEY WENT THROUGH THE RAILROAD TRACKS. THE PATIENT STATED THAT THEY FELT LIKE BEING "ELECTROCUTED". FOLLOW UP INFORMATION REPORTED THAT THE MANUFACTURER'S REPRESENTATIVE HAD CONTACTED THE PATIENT FOR FOLLOW UP, BUT THE PATIENT WAS UNABLE TO MEET AT THE TIME DUE TO FAMILY ISSUES. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. SEE ALSO MANUFACTURER'S REPORT # 3004209178-2013-03328

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTERMITTENT SURGING SENSATION HAPPENED WHEN THE PATIENT GOT IN THE CAR AND WAS DRIVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93410 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR