BEUDAMED
    FDA Adverse Event Other Summary report: N

    IPLAN STEREOTAXY

    MDR report key: 3216988 · Received July 3, 2013

    Report

    Report Number
    8043933-2013-00020
    Event Type
    Other
    Date Received
    July 3, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 4, 2013
    Product Code
    HAW
    PMA / PMN Number
    K053127
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BRAINLAB INVESTIGATION SHOWED THAT APPARENTLY THE HOSPITAL DID USE A LOCALIZER-ARC-COMBINATION THAT WAS NOT VERIFIED BY BRAINLAB AS REQUIRED. A COMPREHENSIVE INVESTIGATION BY BRAINLAB REGARDING THIS SPECIFIC EVENT IS CURRENTLY ONGOING AND FINAL CONCLUSIONS ARE PENDING. BRAINLAB PLANS TO ISSUE A FOLLOW-UP REPORT TO THE FDA UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE FOLLOWING EVENTS HAVE BEEN REPORTED TO BRAINLAB BY THE HOSPITAL: FOR CRANIAL DEEP BRAIN STIMULATION PROCEDURES FOR 4 DIFFERENT PATIENTS THE TRAJECTORY, TO BE APPLIED WITH A STEREOTACTIC ARC, HAS BEEN PLANNED WITH THE AID OF THE BRAINLAB IPLAN STEREOTAXY SOFTWARE. IN EACH OF THESE 4 SURGERIES INTRAOPERATIVELY A SHIFT OF ABOUT 2-4 MM POSTERIORLY HAS BEEN DETECTED. THE SURGERIES HAVE BEEN CONTINUED WITHOUT THE INFORMATION PROVIDED BY THE BRAINLAB DEVICE. THE HOSPITAL INFORMED BRAINLAB THAT EACH OF THESE SPECIFIC PATIENTS HAD AN INTERCEREBRAL HEMORRHAGE DUE TO THIS ISSUE. AT THIS POINT OF TIME, FURTHER INFORMATION REGARDING THE CLINICAL OUTCOME OR ANY LONG-TERM EFFECTS FOR THESE SPECIFIC PATIENTS IS NOT AVAILABLE TO BRAINLAB. DATES OF SURGERIES: SURGERY 1 AND 2: (B)(6) 2013, SURGERY 3 AND 4: (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306345 IPLAN STEREOTAXY PLANNING SYSTEM, STEREOT. INSTRUMENT HAW 21210D NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other