BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 7079175 · Received December 4, 2017

    Report

    Report Number
    3004209178-2017-24789
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Date of Event
    September 27, 2017
    Report Date
    December 11, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169100824
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING GABLOFEN (2000 MCG/ML AT 1202.2 MCG/DAY; LOT #2163-121; EXP 08/19) VIA AN IMPLANTED PUMP. THE PATIENT¿S MEDICAL HISTORY INCLUDED CEREBRAL PALSY WITH SPASTIC QUADRIPARESIS AND SHE BENEFITED FROM INTRATHECAL BACLOFEN. CONCOMITANT MEDICATIONS INCLUDED FLUTICASONE (50 MCG EACH NOSTRIL DAILY), LACTALOSE (10 OZ GTUBE HS + PRN), LEVALBUTERAL (NEBULIZER PRN), LEVETIRAZETAM (100 MG/ML 75 ML PEG BID), DEPOPROGESTERONE (SHOT Q 3 MONTHS), PHENOBARBITAL (20 MG/5 ML 12 ML BID), POLYETHYLENE GLYCOL (17 GM GTUBE DAILY), PYRIDOXAL 5 PHOSPHATE (5 ML DAILY), PYRIDOXINE (100 MG GTUBE DAILY), BACLOFEN (10 MG GTUBE HS), AND DIAZEPAM (75 MG EA PRN). THE INDICATION FOR PUMP USE WAS CEREBRAL PALSY AND INTRACTABLE SPASTICITY. ON (B)(6) 2017 IT WAS REPORTED THAT THEY HAD PERFORMED A DYE STUDY AND A ROTOR STUDY AND DID NOT FIND ANY ISSUES. PER THE REPORTER, THEY WERE ABOUT TO UPDATE THE PUMP WITH THE PRIMING BOLUS UNTIL THEY SAW A CODE ON THE CLINICIAN PROGRAMMER. THE CODE WAS 08:08:F8:F8-544 (253). PER THE COMPANY REPRESENTATIVE THEY WERE SEEING THIS CODE POP UP WHILE THEY WERE UPDATING THE PUMP WITH THE PROGRAMMING INFORMATION. THEY CHECKED THE PUMP AND IT SAID THE PUMP WAS IN STOP MODE. THEY UPDATED THE PUMP WITH THE NEW PROGRAMMING INFORMATION AGAIN AND THE PUMP WAS ABLE TO UPDATE SUCCESSFULLY. PER THE REPORTER AFTER THE PRIMING BOLUS THEY WOULD CHECK THE PUMP AGAIN TO ENSURE THE NEW SETTINGS WERE CORRECT. NO PATIENT SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2017 FROM AN HCP WHO REPORTED THAT THE PATIENT STARTED HAVING CLONUS AROUND 8 PM LAST NIGHT. THE PATIENT¿S MOTHER AND THE HCP THOUGHT IT MAY HAVE SOMETHING TO DO WITH THE PROGRAMMING THAT WAS PERFORMED ON (B)(6) 2017. THE REPORTER HAD NO ADDITIONAL INFORMATION ABOUT THE EVENT AND WAS LOOKING FOR A COMPANY REPRESENTATIVE THAT COULD COME TO THE PATIENT¿S NEXT APPOINTMENT AND ASSIST THE HCP. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2017 FROM AN HCP WHO REPORTED THAT THE BACLOFEN WAS NOT DISCONTINUED AS A RESPONSE TO THE ADVERSE EVENT AND THE PATIENT WAS NOT HOSPITALIZED. THE HCP INCREASED THE BASAL RATE TO 44 MCG/HR AND THE PATIENT WAS GIVEN LORAZEPAM (PRN). THE PATIENT¿S CLONUS WAS BACK TO BASELINE PER THE PATIENT¿S MOTHER. THE REASON FOR THE DYE AND ROTOR STUDY WAS THAT THE PATIENT HAD INCREASED CLONUS AND THERE WAS MORE FLUID DRAINED FROM THE PUMP THAN EXPECTED. THE PUMP HAD NOT BEEN REFILLED AGAIN SINCE THE STUDY. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2017 FROM AN HCP WHO REPORTED THAT THE PUMP REFILL DATES WERE (B)(6) 2017. THEY DID NOT HAVE ANY OF THE ACTUAL OR EXPECTED VALUES OR CAUSES FOR THE VOLUME DISCREPANCY. PER THE HCP, THEY WERE JUST SEEING IF THE PUMP WAS WORKING. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER WHO REPORTED THAT AT THE REFILL ON (B)(6) 2017 THE OLD SOLUTION WAS REMOVED WITHOUT DIFFICULTY AND WASTED. HOWEVER NOTED 12.5CC WAS REMOVED. THE RESERVOIR VOLUME PER REPORT WAS 4.9ML PLUS 2ML EXTRA AND 10% VARIANCE OF 4CC SHOULD HAVE BEEN 10.9. PER THE HEALTHCARE PROVIDER, THIS HAS BEEN INCREASING WITH TIME. THE NEW SOLUTION PF IT GABLOFEN 2000MCG/ML 40CC WAS INSTALLED. THE PUMP WAS THEN REPROGRAMMED A FLEX INFUSION MODE WITH 100MCG AT 1700 AND 2100 AND BASAL RATE AT 41.0MCG/HOUR AND TOTAL DOSE AT 1202.2MCG/DAY. THE RESERVOIR VOLUME WAS SET AT 2 CC. THE PHYSICIAN RECOMMENDED A SIDE PORT STUDY. ON (B)(6) 2017 THE PATIENT CAME IN TO CHECK THE STATUS OF THE INTRATHECAL PUMP. THE COMPANY REPRESENTATIVE REVIEWED THE EVENT LOGS. THE PATIENT HAD STOPPAGE DURING THEIR PROCEDURE (B)(6) AND WHEN HER INFUSION WAS CHANGED ON (B)(6) WITH THE HEALTHCARE PROVIDER BUT THERE HAD BEEN NO EVENTS SINCE 10/9. ESSENTIALLY THIS INDICATES THAT HER PUMP WAS FUNCTIONING. THIS DID NOT EXPLAIN WHY THE HEALTHCARE PROVIDER WITHDREW 1.5CC MORE THAN EXPECTED AT HER LAST REFILL. THEY WOULD CONTINUE TO MONITOR IT. THE PATIENT¿S MOTHER ALSO QUESTIONS WHAT COULD BE DONE TO REDUCE SPASTICITY AND CLONUS BESIDES INTRATHECAL BACLOFEN, POSSIBLY ALLOW HER TO REDUCE HER OVERALL DOSE. THE HEALTHCARE PROVIDER WOULD REVIEW THIS WITH THE PHYSICIAN AS WELL AS OLD RECORDS. THE PATIENT HAD A CHANGE IN STATUS (B)(6). SHE HAD GONE TO THE PUBLIC LIBRARY THAT DAY WHICH HAD AN ALARMED DOOR. THE PATIENT HAD IMPROVED LAST NIGHT. THE PATIENT DID NOT TAKE LORAZEPAM LAST NIGHT AND WAS STABLE TODAY. THE PATIENT¿S REFILL ALARM DATE IS (B)(6) AND THE PATIENT WAS SCHEDULED FOR AN APPOINTMENT ON (B)(6). ON (B)(6) 2017 THE PATIENT WAS SEEN FOR A PUMP REFILL. THE PATIENT¿S FAMILY HAD NOTED INTERMITTENT SPASTICITY TYPICALLY IN THE AFTERNOON. THE PATIENT WAS MUCH IMPROVED FROM WHEN THE PUMP WAS CHECKED FOR MALFUNCTION AND NO ISSUES FOUND. THE PATIENT¿S FATHER RECALLED WHEN THE PUMP WAS FIRST PLACED AND HE DID NOT REALIZE HOW MUCH DISCOMFORT THE PATIENT MUST HAVE BEEN IN. THE PATIENT WAS SO FLEXED AND THEY HAD DIFFICULTY DRESSING HER. AFTER THE PUMP WAS PLACED, THEY COULD SEE THE PATIENT¿S LIMBS RELAXED WHEN PLACED IN BED. DURING THE REFILL THE OLD SOLUTION WAS REMOVED WITHOUT DIFFICULTY AND WASTED THERE WAS 13CC CLEAR FLUID REMOVED. THE RESERVOIR VOLUME EXPECTED WAS 8.2CC¿S PLUS 2CC EXTRA PLACED PLUS 10% VARIANCE. THE GABLOFEN 2000MCG/ML 40CC WAS INSTALLED. THE PUMP WAS THEN REPROGRAMMED A FLEX INFUSION MODE WITH 44.0MCG/HOUR BASAL RATE AND 100MCG BOLUS DOSE OVER 3 MINUTES AT 1700 AND 2100 FOR TOTAL DOSE OF 1250.8MCG/DAY. THE RESERVOIR VOLUME WAS SET AT 1.5CC. THERE WAS NO KNOWN CAUSE FOR ¿MORE FLUID BEING DRAINED FROM THE PUMP¿ PRIOR TO THE DYE AND ROTOR STUDY THAT WAS PERFORMED ON (B)(6) 2017. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859127 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169100824

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR