BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 5191546 · Received October 30, 2015

    Report

    Report Number
    3004209178-2015-21896
    Event Type
    Malfunction
    Date Received
    October 30, 2015
    Report Date
    October 8, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3888-45, LOT# V122051, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V122051, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V122051, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V122051, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37082-20, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37082-20, SERIAL# (B)(4), IMPLANTED: (B)(4) 2009, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THE PATIENT WAS WONDERING IF SHE COULD HAVE A DIFFERENT LEAD PUT IN WHEN THEY REPLACE THE IMPLANTABLE NEUROSTIMULATOR (INS) IN A COUPLE OF YEARS. THE PATIENT HAD SEEN THE X-RAY SHOWING THE COILED LEAD AND HER HUSBAND WANTED HER TO HAVE HER GET IT REPLACED WHILE HE STILL HAD INSURANCE BEFORE HE RETIRED. IT WAS NOTED THE PATIENT STATED WHEN SHE HAD THE IMPLANT PUT IN, THE DOCTOR USED THE WRONG LEAD AND THE LEAD WAS COILED ON THE LEFT SIDE OF THE NECK. IT WAS REVIEWED THE CHOICE WOULD BE BETWEEN THE PATIENT AND THE HEALTHCARE PROVIDER (HCP). THE PATIENT WAS ALSO WONDERING IF THERE WERE SMALLER INSS. THERE WAS NO ALLEGATION OR ANY COMPLAINTS AGAINST THE THERAPY. NO SYMPTOMS WERE REPORTED. RELEVANT MEDICAL HISTORY INCLUDED RADICULAR PAIN SYNDROME. NO INTERVENTIONS WERE REPORTED REGARDING THIS EVENT. 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
    721184 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1