BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6746602 · Received July 27, 2017

    Report

    Report Number
    3004209178-2017-15667
    Event Type
    Injury
    Date Received
    July 27, 2017
    Date of Event
    July 26, 2017
    Report Date
    September 18, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169508156
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE DEVICE SYSTEM; THE OTHER RELEVANT COMPONENTS INCLUDE: PRODUCT ID: 8709SC, SERIAL (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED AND ANALYSIS IDENTIFIED TEARING/CIRCULAR CORING IN THE CUP OF THE SUTURELESS CONNECTOR (SC) CONSISTENT WITH THE TIP OF THE CONNECTOR ON THE PUMP. LEAKING WAS SEEN AT THE CONNECTOR DURING PRESSURE TESTING THAT MET LEAK CRITERIA PER NDHF1162-113599.: CONCLUSION CODE 92 NO LONGER APPLIES. CONCLUSION CODE 67 AND 12 HAVE BEEN APPLIED TO THE CATHETER. RECENT FDA CODING CHANGES OFFER LIMITED OPTIONS FOR MEDICAL DEVICE EVALUATION CONCLUSION CODING. MEDTRONIC SELECTED CONCLUSION CODE 12 BECAUSE, ALTHOUGH THE DEVICE WAS OPERATING WITHIN SPECIFICATIONS, MEDTRONIC MODIFIED THE SPECIFICATIONS MAKING THIS THE CLOSEST CODE AVAILABLE WITH RESPECT TO 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.

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE (REP) ON 2017-JUL-27 REPORTED A CATHETER REVISION OCCURRED. DURING PROCEDURE THE HEALTHCARE PROFESSIONAL (HCP) ASPIRATED RED TINGED FLUID FROM CATHETER ACCESS PORT (CAP). DYE WAS INJECTED, BUT NO CATHETER DEFECT NOTED. THE HCP DISCONNECTED FROM PUMP AND NOTICED CLOTTED BOOT/TISSUE AT SUTURELESS CONNECTOR. AN 8578 USED TO REVISE CONNECTOR. CAP PATENCY TESTED BY HCP AS WELL WHILE PUMP WAS DISCONNECTED FROM CATHETER. CLEAR FLUID ASPIRATED AFTER CATHETER RECONNECTED TO PUMP. IT WAS NOTED AT THE END OF CASE RED TINGED FLUID ASPIRATED AGAIN. A COMPUTED TOMOGRAPHY (CT) OF BRAIN AND SPINE WAS ORDERED. THE DOSE RESUMED WITH AN EXTRA 100 MCG BOLUS ALONG WITH A PRIMING BOLUS. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE (REP) INDICATED THEY HAD NO FURTHER INFORMATION EXCEPT THAT THE PATIENT WAS NOW ¿DOING MUCH BETTER¿ PER THE RESIDENT INVOLVED WITH THE PATIENT¿S CARE. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED OR EXPECTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS RECEIVING 2000 MCG/ML BACLOFEN AT 755.9 MCG/DAY VIA AN IMPLANTABLE PUMP FOR SPINAL PAIN, CEREBRAL PALSY, AND INTRACTABLE SPASTICITY. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2017 WITH SIGNS AND SYMPTOMS OF BACLOFEN WITHDRAWAL. NO ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS WERE NOTED TO HAVE LED OR CONTRIBUTED TO THE ISSUE, HOWEVER IT WAS NOTED THE PATIENT HAD THEIR PUMP REPLACED ON (B)(6) 2017. A DYE STUDY WAS PERFORMED, HOWEVER THEY WERE UNABLE TO ASPIRATE THE CATHETER. THEY DECIDED TO PUSH DYE THROUGH THE CATHETER ACCESS PORT, BUT THEY DID NOT OBSERVE DYE IN THE INTRATHECAL SPACE. A CATHETER REVISION WAS PLANNED FOR LATER THAT DAY AND THE ISSUE WAS UNRESOLVED. THE PATIENT WAS NOTED TO BE "ALIVE - NO INJURY". NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527190 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169508156

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention