BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 2883940 · Received December 21, 2012

    Report

    Report Number
    3004209178-2012-12171
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    December 4, 2012
    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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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; PRODUCT ID 3708240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND HAD LOST RELIEF FOR THE PREVIOUS 2 MONTHS. THE REPORTER INDICATED THAT THE PATIENT NEEDED STIMULATION FROM L1-L4 BUT STIMULATION HAD MOVED LOWER THAN THE PATIENT WOULD HAVE LIKED. THE PATIENT WAS REPORTED TO HAVE HAD A FLEX X-RAY DONE RECENTLY AND IT SHOWED THAT "L4-L5 WAS MOVING AROUND." IT WAS NOTED THAT THE PATIENT WAS DIRECTED BY HIS HEALTHCARE PROVIDER (HCP) TO CONTACT A MEDTRONIC REPRESENTATIVE FOR FURTHER PROGRAMMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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