BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 1868790 · Received October 6, 2010

    Report

    Report Number
    9613347-2010-00027
    Event Type
    Other
    Date Received
    October 6, 2010
    Date of Event
    August 11, 2010
    Report Date
    September 29, 2010
    Manufacturer
    STORZ MEDICAL AG
    Product Code
    LNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER HEALTHTRONICS, SLX LITHOTRIPTOR PASSED SERVICE CHECKS DONE PREVIOUS TO PROCEDURE. THE UNIT WAS EVALUATED THE DAY AFTER THE EVENT ((B)(6) 2010); IT PASSED SERVICE CHECK AND WAS PUT BACK INTO CIRCULATION. NO SERVICE IS PERFORMED BY KARL STORZ ON THIS UNIT AFTER WARRANTY ENDED IN 2001; HEALTHTRONICS PERFORMS ITS OWN SERVICE.

    Description of Event or Problem · 1

    ALLEGEDLY, AT THE CONCLUSION OF A LITHOTRIPSY PROCEDURE IT WAS NOTED THAT THE PT WAS NOT REVIVING. THEY INITIATED A CODE BLUE BUT HOSPITAL PERSONNEL WERE UNABLE TO REVIVE PT; HE EXPIRED. THE PT HAD A PRE-EXISTING CONDITION OF SEVERE HEART DISEASE; THIS WAS ADDRESSED WITH THE IMPLANTATION OF A PACEMAKER 2 YEARS PRIOR TO THIS EVENT. THE FAMILY DECLINED AN AUTOPSY, SO THE HOSPITAL COULD NOT DRAW AN ABSOLUTE CONCLUSION ON WHAT OCCURRED, BUT THEY BELIEVE THAT HE SUFFERED A MYOCARDIAL INFARCTION WHILE ON THE TABLE AND THAT A COMBINATION OF THE AGE OF THE PT AND PRE-EXISTING HEART CONDITION CAUSED THE HEART ATTACK. LITHOTRIPSY UNIT FUNCTIONED WELL; HOSPITAL DID NOT BELIEVE IT WAS A FACTOR IN DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ SLX LITHOTRIPTOR LNS STORZ MEDICAL AG 3819 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death