BEUDAMED
    FDA Adverse Event Death Summary report: N

    KYPHON INFLATABLE BONE TAMP

    MDR report key: 2131802 · Received June 16, 2011

    Report

    Report Number
    2953769-2011-00077
    Event Type
    Death
    Date Received
    June 16, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 20, 2011
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    HRX
    PMA / PMN Number
    K981251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TREATED LEVEL ON (B)(6) 2011 WAS T8. EXAMINATION ON (B)(6) 2011 SHOWED FURTHER FRACTURE OF TREATED LEVEL (T8), AND COMPRESSION FRACTURES OF T7 AND L1. ON (B)(6) 2011 PATIENT WAS ADMITTED TO THE HOSPITAL WITH FEVER OF 103F, VOMITING, INABILITY TO AMBULATE, SEPSIS (LAB WORK CONFIRMED) AND UTI. THE PATIENT EXPIRED IN THE HOSPITAL. RELEVANT HISTORY: CARDIAC-MITRAL AND AORTIC VALVE REPLACEMENT; COPD; CHF; HYPERTHYROIDISM; OSTEOPOROSIS.

    Additional Manufacturer Narrative · 1

    EVAL METHOD: FOLLOW UP WITH PATIENT'S HUSBAND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BALLOON KYPHOPLASTY PROCEDURE ON (B)(6) 2011 AT ONE LEVEL (LEVEL UNKNOWN) AND WAS DISCHARGED HOME ON (B)(6) 2011. REPORTEDLY PATIENT WAS IN "A LOT OF PAIN" AND WAS REFERRED FOR PAIN MANAGEMENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL BY HER CARDIOLOGIST AND WAS SEEN BY HER PHYSICIAN AT THAT TIME. REPORTEDLY, X-RAYS SHOW "TWO ADDITIONAL FRACTURES OF THE SPINE AND QUESTIONABLE LEAKAGE OF CEMENT". POSTOPERATIVELY, THE PATIENT DEVELOPED A URINARY TRACT INFECTION AND EXPIRED FROM SEPTICEMIA. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHON INFLATABLE BONE TAMP ARTHROSCOPE HRX MEDTRONIC SPINE LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Other