BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2903335 · Received January 9, 2013

    Report

    Report Number
    3004209178-2013-00324
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 4, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL 8709SC, LOT # 0204889968, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012. (B)(4). DEVICE RETURNED, ANALYSIS NOT YET COMPLETED. A SUPPLEMENTAL REPORT WILL BE FILED WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO ANOMALIES. ANALYSIS OF THE CATHETER REVEALED A NON-SIGNIFICANT INDENT IN THE SC CONNECTOR SEAL WHICH DID NOT AFFECT INFUSION. THE COMPLETE CATHETER WAS RETURNED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION NO EVAL EXPLAIN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE SYSTEM WAS EXPLANTED DUE TO WOUND BREAKDOWN. THE SYSTEM WAS USED TO INFUSE BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE WOUND DEHISCED 3-4 DAYS AFTER IMPLANT AND CONTINUED TO DEHISCE AFTER BEING RE-SUTURED. ANTIBIOTICS WERE ADMINISTERED, BUT THE WOUND CONTINUED TO WORSEN. THE PUMP WAS EXPLANTED 9 DAYS AFTER IMPLANT. THE PATIENT RETURNED TO BASELINE ON ORAL BACLOFEN AND ATIVAN AS NEEDED. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12923 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00011 YR Required Intervention