BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 5101496 · Received September 24, 2015

    Report

    Report Number
    3004209178-2015-18653
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Report Date
    September 1, 2013
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED FROM ¿PRODUCT PROBLEM¿ TO ¿ADVERSE EVENT <(>&<)> PRODUCT PROBLEM¿ (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3550-39, LOT# N231968, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3 7752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 355031, LOT# N182272, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: SCREENING DEVICE. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT THE PATIENT WAS NOT GETTING STIMULATION ON THE LEFT LEG, AND THE PATIENT WAS TOLD TO MAKE AN APPOINTMENT AT THE HEALTHCARE PROFESSIONAL'S OFFICE. STEPS TAKEN TO RESOLVE THE ISSUE INCLUDED TRYING TO REPROGRAM STIMULATION ON THE LEFT SIDE. NO OUTCOME WAS REPORTED FOR THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT SHE HAS A BROKEN LEAD BECAUSE SHE FELL. THE PATIENT MET WITH A MANUFACTURER REPRESENTATIVE WHO INFORMED HER THAT SHE HAD MORE LEADS AVAILABLE. NO PATIENT SYMPTOMS REPORTED. ADDITIONAL FOLLOW-UP IS BEING CONDUCTED; IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632632 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 00067 YR