BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3241506 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12126
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    June 27, 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
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3778-75, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3550-39, LOT # N288090, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4). ANALYSIS OF THE LEAD FOUND THAT ELECTRODES 0 AND 1 HAD BEEN BROKEN OFF DUE TO OVERSTRESS OR DAMAGE AND HAD NOT BEEN RETURNED. IT WAS ALSO FOUND THAT CONDUCTORS 2, 3, 4, 5, AND 6 WERE BROKEN NEAR THE #7 ELECTRODE. ANALYSIS OF THE TRITON ANCHOR FOUND NO SIGNIFICANT ANOMALY. IT WAS NOTED THAT THE SILICONE PART OF THE TRITON ANCHOR HAD SEPARATED AND HAD NOT BEEN RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING A REVISION OF PERIPHERAL NERVE STIMULATION WITH POSSIBLE REPLACEMENT. THE REASON FOR REPLACEMENT WAS NOTED AS UNKNOWN. IT WAS LATER REPORTED THAT LEAD WAS EXPLANTED DUE TO IMPEDANCES GREATER THAN 10000 OHMS ON ELECTRODES 8-14. IT WAS NOTED THAT THE LEAD WAS REPLACED. THE PATIENT HAD REPORTEDLY EXPERIENCED PAIN IN THE OCCIPITAL REGION. THE REPORTER STATED THAT ELECTRODES 8 AND 9 HAD BEEN SEVERED FROM THE LEAD PRIOR TO THE REVISION AND REMAINED IN THE PATIENT. THE PHYSICIAN DID NOT WANT TO ATTEMPT REMOVAL DUE TO THE LOCATION. IT WAS LATER REPORTED THAT THE PATIENT HAD REQUIRED A REVISION DUE TO LOST STIMULATION. UPON REVISION A LEAD FRACTURE WAS NOTED. IT WAS NOTED THAT THE PATIENT HAD RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340344 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 Required Intervention