BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1901975 · Received November 12, 2010

    Report

    Report Number
    3004209178-2010-09399
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 28, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT'S PUMP AND CATHETER WERE REPLACED ON (B)(6) 2010 (SEE MANUFACTURER'S REPORT #3007566237-2010-07998). ON (B)(6) 2010, THE HEALTH CARE PROFESSIONAL DISCOVERED A CEREBROSPINAL FLUID LEAK. THE HCP APPLIED DURA-SEAL TO THE BACK AREA TO "COVER UP ANY CSF LEAK." THIS DID NOT RESOLVE THE PROBLEM AND THE PATIENT HAD CSF IN HIS BACK AND IN HIS POCKET. THE HCP "WANTED EVERYTHING TO HEAL UP, AND THEN BRING THE PATIENT BACK" SO THE ENTIRE SYSTEM WAS EXPLANTED ON (B)(6) 2010. DURING THE EXPLANT, THE HCP DISCOVERED THAT THE CATHETER WAS FRACTURED. THE HCP REMOVED 16.62 CM OF THE CATHETER AND LEFT 14.3 CM OF THE CATHETER BECAUSE, THE HCP DID NOT FEEL THAT IT WAS APPROPRIATE TO DISSECT DOWN THAT FAR. THE MEDICATIONS BEING DELIVERED VIA THE DEVICE SYSTEM WERE DILAUDID AND BUPIVICAINE. IT WAS NOTED THAT THE DOSAGE WAS BETTER MAINTAINED WITH THIS DEVICE SET THAN WITH THE SET THAT WAS EXPLANTED ON (B)(6) 2010. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention CATHETER: MODEL 8709SC, LOT #N260135015| EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8703, LOT #J94142142| EXPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 863740,| IMPLANTED:| LOT #NGV021192N| IMPLANTED:| IMPLANTED: