BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3734638 · Received April 8, 2014

    Report

    Report Number
    3004209178-2014-05809
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Report Date
    March 18, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3550-39, LOT# N231968, IMPLANTED: (B)(6) 2009, TYPE ACCESSORY. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 355031, LOT# N182272, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: SCREENING DEVICE. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6)2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL THE WEEK PRIOR TO THE REPORT. SINCE THE FALL THE PATIENT WAS NOT FEELING THE STIMULATION GOING DOWN THEIR LEGS LIKE THEY USED TO. THE PATIENT FELT THE STIMULATION BUT IT WAS LIGHT AND NOT AS HEAVY AS IT USED TO BE. SOMETIMES THEY DIDN¿T FEEL THAT ¿IT REALLY DOING IT¿. THE DEVICE WORKED GREAT UNTIL THE FALL. THE PATIENT NOTICED THE CHANGE IN STIMULATION AFTER THE FALL AROUND SUNDAY OR MONDAY. THEY FIRST THOUGHT IT WAS BECAUSE THEY NEEDED TO CHARGE THEIR IMPLANTABLE NEUROSTIMULATOR (INS) BUT WHEN THEY WENT TO CHARGE THE NIGHT PRIOR TO THE REPORT THEY ONLY NEEDED ONE BLOCK FILLED. 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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211621 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 00068 YR