BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4243620 · Received November 11, 2014

    Report

    Report Number
    3004209178-2014-21327
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    February 25, 2014
    Report Date
    October 20, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(4) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN INTER-OPERATIVE HEMATOMA FOUND. AN INCISION AT THE THORACIC SPINE WAS MADE USING AN 11 BLADE. THERE WAS A SMALL SUBCUTANEOUS AND SUBFASCIAL HEMATOMA FOUND. THE HEMATOMA WAS EVACUATED AND COPIOUSLY IRRIGATED. THERE WAS NO ACTIVE BLEEDING. THE PATIENT WAS HOSPITALIZED FOR PAIN CONTROL. THE ETIOLOGY WAS NOTED AS A POSSIBLE POST-OPERATIVE HEMATOMA FROM PREVIOUS LEAD AND EXTENSION IMPLANT. THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727864 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization