BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3601728 · Received January 31, 2014

    Report

    Report Number
    3004209178-2014-01430
    Event Type
    Malfunction
    Date Received
    January 31, 2014
    Date of Event
    January 27, 2012
    Report Date
    January 28, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 37744, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3550-39, LOT# N316092, IMPLANTED: 2012 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 3550-39, LOT# N326622, IMPLANTED: 2012 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3888-33, LOT# V714493, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3888-33, LOT# V894663, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A SURGING SENSATION. IT WAS STATED, THE PATIENT HAD AN APPOINTMENT ON THE DAY OF REPORT TO ¿REBOOT¿ THE BATTERY IN THEIR BACK. IT WAS NOTED THEIR DEVICE HAD BEEN CHARGED AND THEY WERE AT AN APPOINTMENT THE DAY PRIOR TO REPORT AND THEY HAD A SURGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66910 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR