BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4233399 · Received November 6, 2014

    Report

    Report Number
    3004209178-2014-21113
    Event Type
    Injury
    Date Received
    November 6, 2014
    Report Date
    October 15, 2014
    Manufacturer
    MEDTRONIC 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

    PRODUCT ID 8781, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE CATHETER PRO DUCT ID 8781, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP SERIAL NUMBER (B)(4) FOUND NO ANOMALY. ANALYSIS OF THE CATHETER SERIAL NUMBER (B)(4) FOUND SC CONNECTOR TEAR IN SEAL NEAR GUIDE RING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC WITH PAIN AT THE LUMBAR INCISION SITE. THE PATIENT HAD ABNORMAL ERYTHEMA, PAIN, AND SWELLING AT THE LUMBAR INCISION SITE ON 2014 (B)(6). ASPIRATED 2.5 CC OF FLUID THAT REVEALED GRAM POSITIVE COCCI. THE PATIENT WAS STARTED ON IV ANTIBIOTICS AND THE SYSTEM WAS EXPLANTED ON 2014 (B)(6). THE LUMBAR SITE WAS INFECTED AND THERE WAS A POSSIBLE INFECTED PUMP SITE. THE SEVERITY WAS ¿MILD¿. THE PATIENT REQUIRED IN-PATIENT HOSPITALIZATION, AN UNSCHEDULED CLINIC OR OFFICE VISIT. THE EVENT WAS ON-GOING AT THE TIME OF REPORT. THE PUMP WAS USED TO INFUSE DILAUDID, CLONIDINE, BUPIVACAINE AND COMPOUNDED BACLOFEN. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT AN ACTION TAKEN THAT IS ASSOCIATED WITH THIS EVENT WAS THE REPLACEMENT OF A PREVIOUSLY EXPLANTED DEVICE ON (B)(6) 2015. THE STATUS/OUTCOME OF THE EVENT WAS RESOLVED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712615 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Hospitalization| R