BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 2930898 · Received January 28, 2013

    Report

    Report Number
    3004209178-2013-01009
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 8, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S FEET 'BURNED' ALL THE TIME WHILE STIMULATION WAS ON. THE PATIENT HAD HAD REPROGRAMMING DONE 4-5 TIMES AND DURING HIS LAST SESSION ON (B)(6) 2012, THE PATIENT WAS INFORMED THAT THE 'LEAD WAS IN THE WRONG SPOT.' THE REPORTER INDICATED THAT THE PATIENT WAS WORKING WITH HIS HEALTHCARE PROVIDER (HCP) WHO NEEDED A PRINT OUT OF THE LAST REPROGRAMMING SESSION BEFORE HE COULD ASSESS THE PLACEMENT OF THE LEAD. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37981 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1