BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2840792 · Received November 20, 2012

    Report

    Report Number
    3004209178-2012-10585
    Event Type
    Injury
    Date Received
    November 20, 2012
    Report Date
    October 24, 2012
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3777-75 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3777-75 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37754 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID, 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3708140 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP FROM THE HEALTH CARE PROVIDER REPORTED THERE WERE PERIOPERATIVE ANTIBIOTICS ADMINISTERED. THE PATIENT DID NOT HAVE MENINGITIS. SIGNS AND SYMPTOMS INCLUDED SWELLING, DRAINAGE AND INCISIONAL WOUND OPENING. THE PRIMARY LOCATION OF THE INFECTION WAS THE DEVICE POCKET. A CULTURE WAS OBTAINED FROM THE DEVICE POCKET AND THE ORGANISM CULTURED WAS (B)(6). INTRAVENOUS AND ORAL ANTIBIOTICS WERE GIVEN AND THE INFECTION RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SYSTEM WAS EXPLANTED DUE TO AN UNKNOWN INFECTION. THE REPORTER STATED THAT CULTURES WERE TAKEN FROM THE DEVICE POCKET AND FROM THE BLOOD. IT WAS NOTED THAT ANTIBIOTIC TREATMENT WAS NECESSARY, AND THE DATE OF ONSET/DIAGNOSIS OF INFECTION WAS (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL OVERNIGHT WAITING ON THE CULTURES TO DETERMINE THE SOURCE OF INFECTION. THE REPORTER STATED THAT PATIENT SYMPTOMS/COMPLICATIONS INCLUDED "BROKE OUT AT BATTERY SITE." IT WAS UNCLEAR WHAT "BROKE OUT" REFERRED TO. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 Hospitalization| R