BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6215852 · Received December 30, 2016

    Report

    Report Number
    3004209178-2016-27473
    Event Type
    Injury
    Date Received
    December 30, 2016
    Date of Event
    December 9, 2016
    Report Date
    November 21, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169508149
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    INTERROGATION OF THE PUMP DETERMINED IT WAS USED TO INFUSE GABLOFEN [2000 MCG/ML] AT 12.3 MCG/DAY. ANALYSIS OF THE PUMP FOUND NO ANOMALIES AND ANALYSIS OF THE CATHETER FOUND NO SIGNIFICANT ANOMALIES. RESULT CODE AND CONCLUSION CODE NO LONGER APPLY.

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 8709, LOT# L66507, IMPLANTED:(B)(6)1999, EXPLANTED: (B)(6) 2016. PRODUCT TYPE CATHETER. ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. 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.

    Additional Manufacturer Narrative · 1

    CONTINUATION OF D11: PRODUCT ID 8709 LOT# L66507 IMPLANTED: 1999-(B)(6) EXPLANTED: 2016-(B)(6)PRODUCT TYPE CATHETER PRODUCT ID 8590-1 LOT# N223070 SERIAL# IMPLANTED: 2010-(B)(6) EXPLANTED: 2016-(B)(6) PRODUCT TYPE ACCESSORY SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8709, LOT #: L66507, UBD: , UDI#: ASKU H6 UPDATE: THE PREVIOUSLY APPLIED CONCLUSION CODE 71 WAS REPLACED WITH 67. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS PROVIDED BY A HEALTHCARE PROVIDER REGARDING AN IMPLANTABLE INTRATHECAL PUMP INTENDED TO DELIVER LIORESAL (CONCENTRATION 2000), AT AN UNKNOWN DOSAGE, INDICATED FOR INTRACTABLE SPASTICITY AND CEREBRAL PALSY. IT WAS REPORTED THAT THE PUMP AND CATHETER WERE EXPLANTED DUE TO INFECTION ON (B)(6) 2016. NO PATIENT INJURY OCCURRED AND IT WAS STATED THAT THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE REPORTED THAT A FULL EXPLANT OF THE ENTIRE SYSTEM EXCEPT FOR A SMALL FRAGMENT OF TUNNELED CATHETER HAD OCCURRED ON 2016-(B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865479 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169508149

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention