BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3902762 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-12283
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Report Date
    June 3, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3998, LOT# V044850V01, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3998, LOT# V006011, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37082-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 37082-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S STIMULATION WOULD SEEM TO BE WEAKER BY THE AFTERNOON. IT WAS STATED THAT THE WEAKNESS WAS RELATED TO THE AMOUNT OF ACTIVITY THE PATIENT WOULD DO ON THAT GIVEN DAY. IT WAS FURTHER STATED THAT THE PATIENT¿S STIMULATION WOULD SEEM TO BE WEAKER IF HE WOULD DO MORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379038 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 00059 YR