BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3183122 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10735
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 29, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE CATHETER WAS DISCONNECTED BY THE SURGEON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VOLUME DISCREPANCY WAS NOTED DURING A PUMP REFILL. THE EXPECTED RESIDUAL VOLUME (ERV) WAS 3.8 ML AND THE ACTUAL RESIDUAL VOLUME (ARV) WAS 21 ML. THE PUMP WAS SET TO MINIMUM FLOW RATE. IT WAS LATER REPORTED THAT THE ERV WAS 3.8 ML AND THE ARV WAS 20 ML. THE CAUSE OF THE VOLUME DISCREPANCY WAS UNKNOWN. THE PLAN WAS FOR A CATHETER DYE STUDY AND ROTOR STUDY ON (B)(6) 2013. THE PATIENT SYMPTOMS WERE NOTED AS UNDERDOSE SYMPTOMS: THE PATIENT WAS NOT RECEIVING THE DRUG. THE PUMP WAS DELIVERING FENTANYL, BUPIVACAINE AND HYDROMORPHONE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CATHETER DYE STUDY WAS NOT SUCCESSFUL AND THE PATIENT WAS GOING TO HAVE A REVISION, AND THE DATE WAS UNKNOWN. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S SURGERY WAS TENTATIVELY SCHEDULED FOR (B)(6) 2013, AND IT WAS NOTED THE DATE COULD CHANGE. 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 CATHETER WAS DISCONNECTED AT MID LINE, CSF FLOW FROM SPINAL CATHETER. BOLUS FROM PUMP AND UNABLE TO SEE FLOW FROM PUMP SEGMENT. WENT TO POCKET AND DISCONNECTED PUMP, BACK TABLE PRIME COMPLETED WITH DRUG FLOW FROM PUMP. THE CATHETER WAS TRIMMED AND ATTACHED NEW PUMP SEGMENT AND CONNECTED UP SYSTEM AND CSF FLOW FROM CATHETER OBTAINED. SYSTEM RECONNECTED TO PUMP AND CATHETER PRIMED. PATIENT¿S PUMP SET TO SIMPLE CONTINUOUS AT THE SLOWEST RATE. PER MD, 2 KINKS WERE NOTED: ONE AT THE ANCHOR SITE AND ONE AT THE CONNECTION OF THE 8709 AND SC. THE PUMP SEGMENT PRODUCT WAS DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283971 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention