BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3090294 · Received May 2, 2013

    Report

    Report Number
    3004209178-2013-07220
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 19, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DEVELOPED A "LARGE" HEMATOMA OVER THE LEAD AND BATTERY INCISIONS. THE HEMATOMA WAS WORSE OVER THE BATTERY SITE COVERING A SPACE OF APPROXIMATELY 14 INCHES BY 14 INCHES. IT WAS NOTED THAT THE DOCTOR WAS WATCHING THE HEMATOMA FOR SIGNS OF INFECTIONS. IT WAS STATED THAT THE PATIENT WAS AFEBRILE AND HIS WOUNDS WERE RED, BUT CLEAN WITH NO DISCHARGE. IT WAS STATED THAT THE PATIENT WAS COMPLAINING OF PAIN AT THE BATTERY SITE AND IT WAS SWOLLEN AND EXTREMELY BRUISED. IT WAS NOTED THAT THE PATIENT'S ANTIBIOTICS WERE EXTENDED. ALMOST TWO WEEKS LATER IT WAS REPORTED THAT THE HEMATOMA WAS GONE. THE STIMULATION WAS "NORMAL" AND THE PATIENT WAS ABLE TO CHARGE ON (B)(6) 2013 WITH ALL 8 COUPLING BARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191512 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 00082 YR Required Intervention