BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3303914 · Received August 22, 2013

    Report

    Report Number
    3004209178-2013-15020
    Event Type
    Malfunction
    Date Received
    August 22, 2013
    Report Date
    July 29, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37744, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 3587A, LOT# L37692, IMPLANTED: 1996 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 74001, LOT# N240167, IMPLANTED: 2012 (B)(6); PRODUCT TYPE ADAPTER PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: 1996 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING DIFFICULTY RECHARGING HIS DEVICE AND THAT IT WAS NOT RECHARGING. IT WAS NOTED THAT THE PATIENT LIKED THE OLD SYSTEM BETTER WHERE HE DID NOT HAVE TO WEAR A BELT TO CHARGE. THE PATIENT WAS GOING TO CALL THE MANUFACTURER REPRESENTATIVE TO MEET HIM AT HIS DOCTOR¿S APPOINTMENT AND SHOW HIM HOW TO RECHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408117 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