BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4752377 · Received May 6, 2015

    Report

    Report Number
    3004209178-2015-08555
    Event Type
    Injury
    Date Received
    May 6, 2015
    Date of Event
    April 11, 2015
    Report Date
    April 15, 2015
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3998, LOT# VA02J9H, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. PRODUCT ID: 3888-45, LOT# V780541, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-33, LOT# VA00P29, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAS BEEN AT THE HOSPITAL BECAUSE HE CANNOT GET PAIN RELIEF FROM HIS THERAPY/IMPLANT BECAUSE THE IMPLANT WAS NOT CHARGED. THE PATIENT DID NOT HAVE THE EQUIPMENT TO CHARGE HIS IMPLANT OR PATIENT PROGRAMMER TO CHECK THERAPY; THIS EQUIPMENT WAS BEING SENT TO THE PATIENT. THE PATIENT WAS IN A LOT OF PAIN AND NEEDS THERAPY. THE COMPANY REPRESENTATIVE CONFIRMED THE PATIENT WAS HOSPITALIZED. THE PATIENT THOUGHT HE HAD LOST HIS EQUIPMENT BUT IT WAS LOCATED AND WAS FUNCTIONING FINE. SOME REPROGRAMMING WAS DONE TO IMPROVE THE COVERAGE OF HIS LOWER BACK. THE PATIENT WAS TOLD TO TRY THE PROGRAMS AND CALL IF HE HAD ANY QUESTIONS OR NEEDS TO BE REPROGRAMMED. THE PATIENT WAS GRATEFUL AND STATED THE SYSTEM HAS REALLY MADE A DIFFERENCE IN HIS LIFE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297368 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 00058 YR Hospitalization