BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3767296 · Received April 23, 2014

    Report

    Report Number
    3004209178-2014-07716
    Event Type
    Injury
    Date Received
    April 23, 2014
    Date of Event
    May 11, 2012
    Report Date
    April 3, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3982A, LOT# N0025535, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 3550-29, LOT# N250553, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION; PRODUCT ID 74001, LOT# N205587, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ADAPTER; PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS NOTED THAT THE BATTERY HAD BEEN REMOVED BUT NOT THE LEAD WIRES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD AN INFECTION AFTER SHE WAS IMPLANTED IN 2012 WHICH WAS 1.5 YEARS AGO (2 YEARS AGO). IT WAS NOTED THAT THE BATTERY HAD BEEN REMOVED BUT NOT THE LEAD WIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246381 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 00060 YR Required Intervention