BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRAFLEX

    MDR report key: 1870045 · Received October 15, 2010

    Report

    Report Number
    2649622-2010-11904
    Event Type
    Death
    Date Received
    October 15, 2010
    Date of Event
    May 20, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K790462
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT WAS LAST SEEN IN CLINIC (B)(6) 2009 WITH LAST DEVICE CHECK ON (B)(6) 2009 WHICH NOTED DEVICE TO BE FINE. PATIENT FOUND LYING ON FLOOR AT NURSING HOME (B)(6) 2009. WAS CONFUSED, BUT DID NOT SEE PHYSICIAN. NEXT DAY COMPLAINTS OF HEADACHE AND BY (B)(6) 2009, NAUSEA AND DIZZINESS. TAKEN TO ER WHERE CAT SCAN NOTED INTRAPARENCHYMAL BLEED. THE PHYSICIAN DID NOT INTERROGATE THE DEVICE AS THE PATIENT "HAD A PACED RHYTHM WHILE HE WAS THERE." FAMILY CHOSE TO PROCEED WITH COMFORT MEASURES ONLY AND PATIENT DIED (B)(6) 2009. CAUSE OF DEATH WAS INTRACRANIAL HEMORRHAGE SECONDARY TO TRAUMA FROM A FALL, AND CORONARY ARTERY DISEASE. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRAFLEX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 6972 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death