BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5637472 · Received May 6, 2016

    Report

    Report Number
    3004209178-2016-09020
    Event Type
    Injury
    Date Received
    May 6, 2016
    Date of Event
    March 17, 2014
    Report Date
    May 31, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED, AND ANALYSIS FOUND NO EVIDENCE OF ANOMALIES. CONCLUSION CODE 9 NO LONGER APPLIES. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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 PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING INTRATHECAL LIORESAL VIA AN IMPLANTED PUMP. THE CONCENTRATIONS WERE UNKNOWN. THE HCP PROVIDED ITB DOSING OVER TIME AND THE DAILY DOSES WERE AS FOLLOWS: (B)(6) 2013 (DAILY DOSE 543 MCG/DAY), (B)(6) 2013 (595 MCG/DAY), (B)(6) 2013 (634 MCG/DAY), (B)(6) 2013 (634 MCG/DAY), (B)(6) 2013 (634 MCG/DAY), (B)(6) 2014 (634.1 MCG/DAY), (B)(6) 2014 (733.5 MCG/DAY, BASAL RATE 24.1, BOLUS 30), (B)(6) 2014 (700 MCG/DAY, BASAL RATE 29, BOLUS 15), (B)(6) 2014 (674 MCG/DAY), (B)(6) 2014 (674 MCG/DAY, BASAL RATE 28, BOLUS 15), (B)(6) 2014 (750.1 MCG/DAY, BASAL RATE 31, BOLUS 15), (B)(6) 2015 (749.3 MCG/DAY, BASAL RATE 17.1, BOLUS 65.1), (B)(6) 2015 (782.4 MCG/DAY, BASAL RATE 16.6, BOLUS 72.2), (B)(6) 2015 (782.4 MCG/DAY, BASAL RATE 16.6, BOLUS 72), (B)(6) 2015 (828.9 MCG/DAY, BASAL RATE 16.6, BOLUS 80), (B)(6) 2015 (824.7 MCG/DAY ALSO REPORTED AS 924.7 MCG/DAY, BASAL RATE 18.9, BOLUS 82), (B)(6) 2016 (924.7 MCG/DAY, BASAL RATE 18.9, BOLUS 80), (B)(6) 2016 (924.7 MCG/DAY, 18.9 BASAL RATE, 80 BOLUS RATE), (B)(6) 2016 (999.9 MCG/DAY, BASAL RATE 22.1, BOLUS RATE 80), (B)(6) 2016 (1060 MCG/DAY, BASAL RATE 22.1, BOLUS 80), (B)(6) 2016 (1221 MCG/DAY), AND (B)(6) 2016 (1221 MCG/DAY). THE LIORESAL LOT NUMBER, OTHER MEDIATIONS THE PATIENT WAS TAKING AT THE TIME OF THE EVENT AND MEDICAL HISTORY WAS UNABLE TO BE OBTAINED. INDICATIONS FOR USE WERE LISTED AS INTRACTABLE SPASTICITY AND CEREBRAL PALSY. THE EVENT DATE WAS ALSO UNABLE TO BE OBTAINED. THE PATIENT WAS ON THE SURGERY SCHEDULE FOR (B)(6) 2016. THE PATIENT WAS HAVING INTERMITTENT WITHDRAWAL SYMPTOMS. THE PATIENT WAS "TOO LOOSE" ON (B)(6) 2014 AND EXPERIENCED WITHDRAWAL SYMPTOMS ON (B)(6) 2014, (B)(6) 2015, (B)(6) 2016, AND (B)(6) 2016. IT WAS ALSO NOTED THE PATIENT EXPERIENCED ACUTE ILLNESS ON (B)(6) 2016. THE PATIENT'S DOSE WAS ESCALATED. THE PATIENT DID NOT EXPERIENCE WITHDRAWAL SYMPTOMS ON (B)(6) 2016 OR (B)(6) 2016. THE HCP DID NOT FIND ANYTHING WHILE TROUBLESHOOTING, BUT THEY WOULD CONSIDER REVISING HIS CATHETER AS WELL AS POSSIBLY SEND FOR ANALYSIS. THE HCP "REALLY FELT SOMETHING WAS NOT RIGHT" AND THE PATIENT "HAD THE OLD CATHETER TOO". THE HCP NOTED THEY COULD START HIM AT THE 700 DOSE POST-IMPLANT, OBSERVE FOR A FEW DAYS FOR WITHDRAWAL AND THEN TITRATE. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THIS REPORT AND THE PATIENT'S STATUS WAS "ALIVE- NO INJURY". IT WAS FURTHER REPORTED THE PATIENT WAS SCHEDULED FOR ITB PUMP REPLACEMENT ON (B)(6) 2016 (THE DATE OF REPLACEMENT WAS UNCLEAR AS REPORTED). THE CONCENTRATION OF LIORESAL, THE LOT NUMBER, OTHER MEDICATIONS THE PATIENT WAS TAKING AT THE TIME OF THE EVENT, MEDICAL HISTORY, TROUBLESHOOTING PERFORMED, DIAGNOSTICS PERFORMED WITH RESULTS, AND THE CAUSE OF THE CATHETER ISSUE WERE NOT REPORTED. ON (B)(6) 2016, (B)(6) (REP, HCP) ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER AND COMPANY REPRESENTATIVE. AT THE TIME OF THE EVENT THE PATIENT WAS ALSO TAKING ORAL BACLOFEN AS NEEDED. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED DYSTONIA AND DYSKINETIC CP (CEREBRAL PALSY). TROUBLESHOOTING AND DIAGNOSTICS INCLUDED A CAP (CATHETER ACCESS PORT) STUDY WITH SPIRAL CT (COMPUTED TOMOGRAPHY) AND LOGS. INTERVENTIONS INCLUDED INCREASING THE INTRATHECAL BACLOFEN DOSE AND EXPLORATION IN THE OR (OPERATING ROOM). AFTER REMOVING THE EXISTING PUMP, THE EXISTING CATHETER WAS ASPIRATED. THE CATHETER FLOWED EASILY, WITHOUT RESISTANCE. PER MD, A DYE STUDY HAD BEEN DONE PREVIOUSLY (DATE UNKNOWN) WHICH ALSO SHOWED CATHETER WAS IN THE INTRATHECAL SPACE. AFTER CONSULTING WITH THE MANAGING MD VIA PHONE, IT WAS ELECTED TO REPLACE ONLY THE PUMP (DUE TO UPCOMING ERI). IT WAS ALSO NOTED IT WAS REPLACED TO PROVIDE A HIGHER RESERVOIR VOLUME. IT SEEMED CLEAR TO THE MD THAT THE CATHETER WAS NOT THE ISSUE. THE OLD PUMP WAS EXPLANTED AND MD REQUESTED IT BE SENT BACK FOR ANALYSIS. THE DOSE WAS NOT ADJUSTED ON THE NEW PUMP - LIORESAL 2000 MCG/ML, 715 MCG/DAY. THE CAUSE OF THE ISSUE WAS NOT DETERMINED; THE MD BELIEVED THAT THE PATIENT'S GROWTH IN HEIGHT/WEIGHT ACCOUNTED FOR THE REASON FOR NEED FOR INCREASING DOSE OVER TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291501 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention