BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 5129218 · Received October 5, 2015

    Report

    Report Number
    3004209178-2015-20054
    Event Type
    Malfunction
    Date Received
    October 5, 2015
    Date of Event
    June 21, 2010
    Report Date
    September 14, 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: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3550-39, LOT# N243261, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-45, SERIAL# (B)(4), IMPLANTED:(B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED A LOSS OF STIMULATION. THE IMPLANT WAS NOT WORKING FOR THE PAST COUPLE OF YEARS, SINCE 2013, AND THERAPY DID NOT WORK FOR HER SINCE IMPLANT. SHE WISHED SHE NEVER WOULD HAVE HAD IT IMPLANTED. IT WAS NOTED THAT THE PATIENT HAD A FALL IN (B)(6) 2015, BUT THE PATIENT WAS HAVING ISSUES WITH THE THERAPY BEFORE THE FALL OCCURRED. THE PATIENT WANTED TO HAVE THE DEVICE TAKEN OUT. SHE WAS CONTACTING HER IMPLANT SURGEON'S OFFICE TO DISCUSS AN EXPLANT. THE PATIENT ALSO REPORTED NOT BEING ABLE TO RECHARGE HER IMPLANTABLE NEUROSTIMULATOR (INS), BUT IT WAS UNKNOWN WHEN IT OCCURRED. HER CURRENT DOCTOR TOLD HER THE LEADS WERE NOT IN THE CORRECT POSITION; THE EVENT DATE WAS UNKNOWN. IT WAS NOTED THAT THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDES INTERCOSTAL NEURALGIA. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659810 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 00058 YR