BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2832137 · Received November 14, 2012

    Report

    Report Number
    3004209178-2012-10259
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD HER SYSTEM EXPLANTED. THE PATIENT HAD AN INFECTION THAT REQUIRED ANTIBIOTIC TREATMENT AND SHE WAS HOSPITALIZED. . A CULTURE WAS TAKEN FROM THE DEVICE POCKET AND BLOOD. THE PATIENT'S SYMPTOMS WERE FEVER, REDNESS, AND SWEATING. THE PATIENT SUSTAINED NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| R