BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3841214 · Received May 30, 2014

    Report

    Report Number
    3004209178-2014-09916
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    May 12, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708220, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 37092, LOT # 283350001, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID 3888-33, LOT # V744030, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3888-33, LOT # V744030, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3888-33, LOT # V744030, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3888-33, LOT # V744030, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2012, THE PATIENT UNDERWENT A PROCEDURE THAT INCLUDED THE REMOVAL OF THE IMPLANTABLE NEUROSTIMULATOR (INS) THAT WAS NOT PROVIDING PAIN RELIEF. IT WAS NOTED THAT THE PATIENT HAD A PUMP IMPLANTED. IT WAS NOTED THAT ¿AFTER THE (B)(6) IMPLANT, AND PROBABLY DUE TO ALL THE SCARING AND HOLES CREATED BY THE REMOVAL OF THE INS AND WIRES, THE PATIENT DEVELOPED A WOUND THAT WAS INFECTED WITH A DEEP INFECTION PENETRATION CENTERED ON THE SPINE.¿ IT WAS NOTED THAT A CT VALIDATION AND OTHER TESTS WERE PERFORMED AND ALL THE WOUNDS WERE DRESSED AND TREATED TO HEAL. REFER TO MANUFACTURING REPORT # 3004209178-2014-09679.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319092 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 00053 YR Required Intervention