BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE ANCHOR 020-1101 WITH ALIGNMENT ROD

    MDR report key: 4819555 · Received June 4, 2015

    Report

    Report Number
    1723170-2015-00651
    Event Type
    Malfunction
    Date Received
    June 4, 2015
    Date of Event
    May 6, 2015
    Report Date
    July 28, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAO
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT PROVIDED BY REPORTER. EXACT BRAND/MODEL/CATALOG NOT PROVIDED. DEVICE LOT NUMBER, OR SERIAL NUMBER, NOT AVAILABLE. OPERATOR OF DEVICE IS A MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE, SPECIALLY TRAINED TO USE THE LASER INDUCED THERMAL THERAPY SYSTEM. PRODUCT IS CLASS I FOR US REGULATIONS AND DOES NOT REQUIRE A 510(K) DESIGNATION. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. NO PARTS HAVE BEEN RETURNED TO MANUFACTURER FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    CORRECTION: IT WAS DISCOVERED ON 27-JAN-2016, THAT AN INCORRECT DATE WAS REFERENCED IN A PREVIOUS SUPPLEMENTAL 3500A SUBMISSION. THE REPORTED DATE OF 16-AUG-2016 WAS REPORTED INCORRECTLY AND SHOULD BE 16-AUG-2015.STATEMENT IN PREVIOUS SUPPLEMENTAL 3500A SUBMISSION SHOULD READ: ¿ON 30-JUN-2015, IT WAS NOTICED THAT A CODING ERROR IN MDR SUBMISSIONS FROM OUR FACILITY RESULTED IN THE MAUDE DATABASE INCORRECTLY CODING THE DEVICES RELATED TO OUR MDR SUBMISSIONS FROM 25-MAY-2015 TO 16-AUG-2015. THE DECISION TO WAIT UNTIL THE DATABASE WAS CORRECTED WAS MADE AFTER CONSULTATION WITH THE FDA AS ADVISED BY A CONSUMER SAFETY OFFICER WITH THE INFORMATION ANALYSIS BRANCH, DIVISION OF POST MARKET SURVEILLANCE, OFFICE OF SURVEILLANCE AND BIOMETRICS. AN IT SOLUTION WAS IMPLEMENTED ON 16-AUG-2015. THIS MDR WAS SUBMITTED TO CORRECT THE CODING ERROR. THERE IS NO NEW INFORMATION TO CHANGE THE PATIENT INFORMATION, EVENT DESCRIPTION AND/OR MANUFACTURER NARRATIVE THAT WAS PREVIOUSLY REPORTED.¿

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER, AGE AND SEX NOW PROVIDED. THE CORRESPONDING JOURNAL ARTICLE ("COMPLICATION AVOIDANCE IN LASER INTERSTITIAL THERMAL THERAPY: LESSONS LEARNED." R. PRUITT, BS; A.GAMBLE, DO; K BLACK, MD; M. SCHULDER, MD; A.D. MEHTA, MD, PHD) RELATING TO THIS AMERICAN ASSOCIATION OF NEUROLOGICAL SURGEONS (AANS) LECTURE WAS PUBLISHED IN JUNE 2016 AND PROVIDED ADDITIONAL INFORMATION REGARDING THIS EVENT, SPECIFICALLY: FOUR PATIENTS (CASES 6 - REPORTED IN 1723170-2015-00653, CASE 9 - REPORTED IN 1723170-2015-00652, CASE 33 - REPORTED IN 1723170-2016-01317, AND CASE 40 -1723170-2015-00651) HAD SUBOPTIMAL CATHETER POSITIONING. THE AUTHOR IDENTIFIED A FACTOR THAT MAY HAVE BEEN ASSOCIATED WITH THE SUBOPTIMAL CATHETER POSITIONING IN CASE 40 INCLUDED USE OF MULTIPLE DEVICES. THE AUTHOR STATES: ¿WE ADAPTED OUR TECHNIQUE ACCORDINGLY TO RELY ON FRAME-BASED STEREOTAXY, USE AN ALIGNMENT ROD, AND PLACE AS FEW DEVICES AS POSSIBLE. WE OFTEN NOTED A SMALL ANGULAR DISPLACEMENT OF PLASTIC SKULL ANCHORS AFTER INSERTING THEM PRIOR TO PLACEMENT OF THE LASER DEVICE AND BELIEVE THAT THIS MIGHT HAVE BEEN THE SOURCE OF A NUMBER OF CASES IN WHICH THERE WAS DEVICE MALPOSITION. WE ABANDONED THESE PLASTIC SKULL ANCHORS FOR TITANIUM DEVICES AFTER OUR 40TH PATIENT AND HAVE NOT HAD A MALPOSITIONED DEVICE SINCE.¿ AND: ¿OF THE 62 DEVICES PLACED, 47 WERE WITH THE USE OF A STEREOTACTIC FRAME. OF THESE 47, 2 HAD INACCURATE CATHETER PLACEMENT, GIVING AN OVERALL ACCURACY OF 95.7% WITH A FRAMED APPROACH. ONE INSTANCE OF DEVICE MALPOSITION OCCURRED WHEN AN ALIGNMENT ROD WAS NOT USED FOR A LONG TRAJECTORY. A CHI-SQUARE ANALYSIS DEMONSTRATED THAT OBSERVED FREQUENCIES OF PROBE MISPLACEMENT WITH PAD VERSUS FRAMED TECHNIQUE EXCEEDED EXPECTED RATES (P = 0.022). WHILE INITIALLY OUR PATIENTS UNDERWENT DEVICE PLACEMENT WITH THE USE OF THE PLASTIC SKULL ANCHOR SUPPLIED BY VISUALASE, WE HAVE FOUND BETTER SUCCESS WITH METAL SKULL ANCHORS. ALL 10 CATHETERS PLACED USING THESE ANCHORS, WHICH ARE TYPICALLY USED TO PLACE STEREOELECTROENCEPHALOGRAPHY ELECTRODES, HAD ACCURATE PLACEMENT. WHILE THESE DIFFERENCES WERE NOT FOUND TO BE STATISTICALLY SIGNIFICANT (P = 0.36, CHI-SQUARE TEST), THIS IS MOST LIKELY DUE TO THE LACK OF STATISTICAL POWER GIVEN THE OVERALL LOW FREQUENCY OF THIS ADVERSE EVENT. NOTWITHSTANDING, BY PROVIDING A RIGID FIXATION TO THE BONE, WE BELIEVE THAT USE OF A METAL ANCHOR BOLT IS LIKELY TO BE THE MOST IMPORTANT FACTOR IN ACHIEVING ACCURATE CATHETER PLACEMENT FOR DEEP TARGETS. HOWEVER, AS A METAL SKULL ANCHOR MAY INTERFERE WITH THERMOMETRY, PLASTIC SKULL ANCHORS MAY BE PREFERRED FOR TREATMENT OF SUPERFICIAL TARGETS (E.G., UP TO 2 CM DEEP TO THE CORTICAL SURFACE).¿ ¿WHILE WE HAVE INDEED MODIFIED OUR TECHNIQUE BASED ON OUR EXPERIENCE OF THE COMPLICATIONS DESCRIBED ABOVE; ANY CONCLUSIONS DRAWN SHOULD BE TEMPERED BY THE FACT THAT THE OVERALL COMPLICATION RATE IS LOW AND THAT OFTEN CERTAIN METHODS (E.G., FRAMELESS STEREOTAXY) ARE ABANDONED WITH RELATIVELY SMALL NUMBERS ON THE BASIS OF JUDGMENTS THAT ARE BASED ON EXPERIENCE, NOT STATISTICS. THEREFORE, IT IS DIFFICULT TO MAKE FORMAL RECOMMENDATIONS GROUNDED IN STATISTICS REGARDING VARIOUS ASPECTS OF THE TECHNIQUE.¿ ¿OUTCOMES SUCCESSFUL OUTCOME USING LITT SEIZURE AND TUMOR CONTROL HAS BEEN EXTENSIVELY DESCRIBED. EVEN IN OUR PATIENTS WHO EXPERIENCED EITHER SUBOPTIMAL TREATMENT OR COMPLICATION, THE MAJORITY OF PATIENTS DID WELL POSTOPERATIVELY. OF THE 6 PATIENTS WITH TUMORS, 4 ACHIEVED LOCAL CONTROL. ALL 5 EPILEPSY PATIENTS WHO EXPERIENCED EITHER COMPLICATION OR SUBOPTIMAL LASER FIBER PLACEMENT HAVE SEEN SOME IMPROVEMENT IN THEIR SEIZURES. PERHAPS THE GREATEST CAUTION RAISED BY OUR RETROSPECTIVE REVIEW INVOLVES CASES OF HYPERTHERMIA-INDUCED INJURY, WHERE COMPLICATIONS RESULTED IN NEUROLOGICAL DEFICIT.¿ THE ARTICLE CONCLUDES: ¿THE PURPOSE OF THIS STUDY WAS TO DISCUSS THE COMPLICATIONS WE EXPERIENCED WITH THIS TECHNOLOGY AND EVALUATE OUR LESSONS LEARNED. ACCURACY OF CATHETER PLACEMENT MAY BE OPTIMIZED BY USING A STEREOTACTIC FRAME WITH A METAL SKULL ANCHOR, WHICH SHOULD BE PLACED OVER AN ALIGNMENT ROD THAT PASSES THROUGH BOTH THE FRAME AND THE BOLT.¿ [¿] ¿LITT IS A PROMISING NEW TOOL FOR THE TREATMENT OF PATIENTS WITH BRAIN TUMORS AND EPILEPSY. AS IS THE CASE WHEN ADOPTING ANY NEW TECHNOLOGY, A CAREFUL AND HONEST EVALUATION OF SUBOPTIMAL CIRCUMSTANCES WILL RESULT IN REFINEMENT OF TECHNIQUE AND IMPROVED CLINICAL OUTCOMES.¿ JOURNAL ARTICLE IS ATTACHED. CITATION: PRUITT, RACHEL, ET AL. "COMPLICATION AVOIDANCE IN LASER INTERSTITIAL THERMAL THERAPY: LESSONS LEARNED." JOURNAL OF NEUROSURGERY (2016): 1-8. RETRIEVED FROM HTTP://THEJNS.ORG/DOI/ABS/10.3171/2016.3.JNS152147.

    Description of Event or Problem · 1

    DURING THE AMERICAN ASSOCIATION OF NEUROLOGICAL SURGEONS (AANS) ANNUAL MEETING A PRESENTER REPORTED MISPLACEMENT WITH PLASTIC ANCHOR: LASER PLACEMENT CAN BE DIFFICULT WITH THE PLASTIC BONE ANCHOR. THE DATES WHEN THIS ISSUE OCCURRED WERE NOT PROVIDED DURING THE LECTURE, NOR WAS ANY PATIENT INFORMATION. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362628 BONE ANCHOR 020-1101 WITH ALIGNMENT ROD INSTRUMENT, SURGICAL, NON-POWERED HAO MEDTRONIC NAVIGATION, INC. (LOUISVILLE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR