BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2772378 · Received October 4, 2012

    Report

    Report Number
    3004209178-2012-08879
    Event Type
    Injury
    Date Received
    October 4, 2012
    Date of Event
    August 30, 2012
    Report Date
    September 5, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER, PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3550-41, LOT# N332922, IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED SYMPTOMS INCLUDE DRAINAGE OR INCISION WOUND OPENING, REDNESS AND SWELLING AT THE DEVICE POCKET. PATIENT HAD PERSISTENT SWELLING, AND POOR WOUND HEALING. DIFFERENTIAL DIAGNOSIS FOUND THE SYMPTOMS AS ALLERGIC REACTION VERSUS INFECTION. EVENT OCCURRED DURING DEVICE FOLLOW-UP. SURGICAL INTERVENTION WAS REQUIRED AND DEVICE WAS EXPLANTED. THERE WERE NO RESIDUAL ADVERSE EFFECTS. PATIENT WAS ALIVE WITH NO INJURY OR ADVERSE EVENT.

    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 00053 YR Required Intervention