BEUDAMED
    FDA Adverse Event Other Summary report: N

    IPLAN RT DOSE

    MDR report key: 2492466 · Received March 8, 2012

    Report

    Report Number
    8043933-2012-00003
    Event Type
    Other
    Date Received
    March 8, 2012
    Date of Event
    October 7, 2009
    Report Date
    February 13, 2012
    Manufacturer
    BRAINLAB AG
    Product Code
    MUJ
    PMA / PMN Number
    K080888
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE HOSP, FOR 2 OF THE 7 PTS THE FOLLOWING WAS OBSERVED: THE PT WITH RADIATION TREATMENT PLAN APPROVED BY HOSP ON (B)(6) 2011 RECEIVED A REPORTED 12% UNDERDOSE, AND THERE WAS NO EFFECT (NEITHER POSITIVE NOR NEGATIVE) FROM THE RADIATION TREATMENT. AS THERE ARE PTS, WHICH DO NOT REACT TO RADIATION THERAPY TREATMENTS, THE HOSPITAL IS NOT SURE WHETHER THIS EFFECT MIGHT BE RELATED TO THE REPORTED UNDERDOSE. THE PT WITH RADIATION TREATMENT PLAN APPROVED BY HOSPITAL ON (B)(6) 2010 RECEIVED A REPORTED 10% OVERDOSE, AND NEUROPATHY WAS OBSERVED FOR THIS PT AFTER TREATMENT. SINCE NEUROPATHY CAN ARISE FOR THESE TYPES OF INDICATIONS GENERALLY, THE HOSPITAL IS NOT SURE WHETHER THIS EFFECT MIGHT BE RELATED TO THE REPORTED OVERDOSE. BRAINLAB CONCLUSION: ALTHOUGH THERE HAS BEEN NO PT INJURY NOR ANY ADVERSE EVENT REPORTED BY ANY OTHER HOSP REGARDING THIS SPECIFIC ISSUE, A RISK TO PT HEALTH COULD NOT BE EXCLUDED. ON JANUARY 9, 2012, THIS CUSTOMER SENT AN EMAIL TO BRAINLAB WITH QUESTIONS REGARDING DOSE SIMULATIONS. THE EVENT DETAILS, THE NUMBER OF POTENTIALLY AFFECTED PTS AT THIS SPECIFIC HOSPITAL AND ROOT CAUSE(S) WERE KNOWN TO BRAINLAB ON FEBRUARY 14, 2012. FOR DETAILS, PLEASE REFER TO THE ATTACHED PRODUCT NOTIFICATION INFO. BRAINLAB INTENDS THE FOLLOWING CORRECTIVE ACTIONS: POTENTIALLY AFFECTED CUSTOMERS RECEIVE A PRODUCT NOTIFICATION INFO (ATTACHED). BRAINLAB WILL PROVIDED UPDATED INSTRUCTIONS FOR USE TO POTENTIALLY AFFECTED CUSTOMERS. TENTATIVELY PLANNED AVAILABILITY: JUNE 2012.

    Description of Event or Problem · 1

    BRAINLAB HAS BECOME AWARE OF EVENTS AT THIS SPECIFIC HOSPITAL WHERE THE ACCURACY OF THE BRAINLAB RADIOTHERAPY TREATMENT PLANNING SOFTWARE WAS NOT WITHIN CLINICALLY DESIRABLE LIMITS FOR VERY SMALL MULTI-LEAF-COLLIMATOR (MLC) FIELD SIZES. POTENTIALLY AFFECTED ARE 7 PTS AT THIS SPECIFIC HOSP WITH RADIATION TREATMENT PLANS APPROVED ON: (B)(6) 2009, (B)(6) 2010, (B)(6) 2011. THE RADIATION TREATMENTS WERE TREATMENTS OF TRIGEMINAL NEURALGIA. THE DEVIATIONS OF THE DOSE SIMULATION FROM THE INTENDED DOSES RANGE FROM CA. 12% UNDERDOSE TO CA. 12% OVERDOSE FOR THESE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPLAN RT DOSE RADIATION THERAPY TREATMENT PLANNING SYS MUJ BRAINLAB AG 21213F; E; F NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other