BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3173732 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10476
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 29, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3998, LOT # V044336, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3998, LOT # LB5191, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 3708240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 37743, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE RECHARGER; PRODUCT ID 748940, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 748940, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION WOULD BE PERFORMED ONE DAY AFTER THE REPORT. THE PATIENT WAS IMPLANTED WITH NEW INS (IMPLANTABLE NEUROSTIMULATOR) A FEW WEEKS PRIOR TO THE REPORT. IT WAS STATED THAT INTRA-OPERATIVE IMPEDANCES WERE "HIGH" AND THAT THIS ISSUE WITH THE LEADS WOULD BE ADDRESSED AT THE REVISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT¿S EXTENSION WAS BAD AND IT WAS REPLACED. IT WAS STATED THE PATIENT HAD NORMAL INTRAOPERATIVE IMPEDANCES AND THEY HAD GOOD COVERAGE. IT WAS LATER REPORTED, THERE WERE NO VISIBLE DEFECTS ON THE EXTENSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273903 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 00055 YR Required Intervention