BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 4345624 · Received December 19, 2014

    Report

    Report Number
    3004209178-2014-24270
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Report Date
    November 21, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3986A60, LOT # N203835, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3986A60, LOT # N203918, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708340, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3708340, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE STIMULATION IS TURNED ON THE IMPLANTABLE NEUROSTIMULATOR (INS) KEPT CUTTING OFF AND WAS NOT HOLDING A CHARGE. THE PATIENT WAS HAVING AN UPCOMING SURGERY FOR A FUSION. IT WAS NOTED THAT THEY HAD FOUND A TUMOR ON THEIR BACK. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT HAD NOT REPORTED ANY DEVICE PROBLEMS OR CONCERNS TO THEIR PHYSICIAN¿S OFFICE ON (B)(6) 2014. THE PATIENT HAD BEEN REFERRED TO AN ORTHOPEDIC SPECIALIST. THEY HAD NOT RECEIVED DEFINITIVE INFORMATION ON WHAT TYPE OF MASS IT WAS. IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE HAD NOT SEEN THE PATIENT AND THEIR TEAM HAD NOT EITHER. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838739 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