BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3141303 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08500
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 14, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 3778-60, SERIAL# (B)(4), EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 3778-60, SERIAL# (B)(4), EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 3778-60, SERIAL# (B)(4), EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN INFECTION AT THEIR POCKET SITE AND THEIR IMPLANTABLE NEUROSTIMULATOR (INS) AND LEADS WERE EXPLANTED. IT WAS STATED A CULTURE WAS TAKEN FROM THE DEVICE POCKET AT THE TIME OF EXPLANT BUT THE ORGANISM WAS UNKNOWN. IT WAS NOTED THE PATIENT HAD SYMPTOMS OF REDNESS, DRAINAGE AND INCISIONAL WOUND OPENING AT THEIR DEVICE POCKET AND LEAD LOCATION. REPORTEDLY, THE PATIENT REQUIRED SURGICAL INTERVENTION, INTRAVENOUS ANTIBIOTIC TREATMENT AND HOSPITALIZATION. IT WAS STATED THE DATE OF ONSET OR DIAGNOSIS OF THE INFECTION WAS UNKNOWN. THE PATIENT¿S STATUS AT THE TIME OF REPORT WAS REPORTED AS NO INJURY OR ADVERSE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245023 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 00042 YR Hospitalization| R