BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 8793059 · Received July 16, 2019

    Report

    Report Number
    3004209178-2019-13574
    Event Type
    Injury
    Date Received
    July 16, 2019
    Date of Event
    July 15, 2019
    Report Date
    October 23, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169100824
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0497-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER REPORTED THE PATIENT'S PUMP WAS BEING REPLACED TODAY AND WOULD BE SENT BACK FOR ANALYSIS. IT WAS NOTED THE CAUSE OF THE MOTOR STALL WAS NOT DETERMINED. THE PUMP STALLED AGAIN ON (B)(6) 2019 AND THE PATIENT WAS STARTED ON ORAL BACLOFEN. THE ISSUE WAS NOT RESOLVED AS THE SURGERY WAS PENDING TO REPLACE THE PUMP. THE PATIENT'S WEIGHT WAS 164 LBS.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED, AND ANALYSIS FOUND CORROSION AND-OR WEAR AND-OR LUBRICATION AND STALL DUE TO SHAFT-BEARING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPOT. A FOLLOW-UP REPORT WILL BE SENT ONCE ANALYSIS IS COMPLETE. THE PATIENT CODE AND EVALUATION CODES HAVE BEEN UPDATED FOR THIS EVENT. 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 REGARDING A PATIENT RECEIVING UNKNOWN BACLOFEN (2000 MCG/ML AT 665.2 MCG/DAY) VIA AN IMPLANTED PUMP. THE INDICATION FOR USE WAS INTRACTABLE SPASTICITY. IT WAS REPORTED A MOTOR STALL WAS SEEN AT INITIAL INTERROGATION, ON (B)(6) 2019, AND THE PATIENT HAD NOT HAD AN MRI RECENTLY. IT WAS NOTED THE MOTOR STALL OCCURRED AT 2:59 AM AND THE RECOVERY OCCURRED AT 3:52 AM THE SAME DAY. THE PATIENT HAD A CARDIAC MONITORING SYSTEM THAT THEY WEAR AT NIGHT AND WAS WONDERING IF THIS COULD STALL THE PUMP. TSS REVIEWED MAGNETIC STRENGTH IN IFP REGARDING MOTOR STALLS. NO SYMPTOMS WERE NOTED AND THE PATIENT WAS INSTRUCTED TO CONTACT THEIR HCP IF ANOTHER STALL OCCURS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURE REPRESENTATIVE (REP). THE REP REPORTED THE PATIENT'S PUMP WAS REPLACED ON (B)(6) 2019 DUE TO THE MOTOR STALL. THE BACLOFEN PUMP DOSE WAS DECREASED AND THE PATIENT WAS STARTED ON ORAL BACLOFEN. IT WAS INDICATED THE PUMP WAS DELIVERING 2000 MCG/ML OF GABLOFEN. THE ALARM HAD BEEN SILENCED. IT WAS REPORTED THE PATIENT HAD EXPERIENCED A SUDDEN LOSS OF THERAPY DUE TO THE REPORTED MOTOR STALL AND A DYE STUDY WAS PERFORMED. IT WAS REPORTED THE DEVICE HAD BEEN USED WITH/IN THE PATIENT FOR TREATMENT, THERE WAS NO PATIENT DEATH OR INJURY, AND THE PATIENT HAD RECOVERED WITHOUT SEQUELA FOLLOWING DEVICE REMOVAL. THE PUMP WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER REPORTED THE PATIENT'S PUMP STALLED AGAIN LAST NIGHT AT 9:36PM (B)(6) 2019 AND THEY HAVE NO ENVIRONMENTAL CAUSE TO TURN TO. IT WAS NOTED THAT THE CARDIAC MONITORING SYSTEM COMPANY AND THERE IS NO EMI ASSOCIATED WITH THAT DEVICE. CALLER STATES THE HCP HAS BEEN SUPPLEMENTING THE WITH PO. IT WAS NOTED THE PUMP HAD NOT RECOVERED AT THIS TIME. CALLER STATES THE PATIENT HAD LIORESAL, WITH THE SAME CONCENTRATION AND DOSE DOCUMENTED IN THIS RECORD. IT WAS NOTED THE ALARM WAS SILENCED AND THEY PROGRAMMED THE PUMP TO SIMPLE CONTINUOUS AT 100 MCG/DAY IN THE UNLIKELY CHANCE THE PUMP WERE TO RECOVER - IT WILL START UP AT 100 MCG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586414 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169100824

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention