BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3982783 · Received August 6, 2014

    Report

    Report Number
    3004209178-2014-14000
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    May 30, 2014
    Report Date
    July 14, 2014
    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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND NO ANOMALY. ANALYSIS OF THE CATHETER FOUND THAT THE CATHETER BODY HAD SIGNIFICANT TWISTING THAT MAY HAVE AFFECTED INFUSION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4). H3 ¿ THE PUMP AND CATHETER WERE RETURNED FOR ANALYSIS. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE SUBSTANCE FOUND IN THE POCKET DURING THE CATHETER REVISION WAS REPORTED TO BE ¿WHITE THICK BUT NON-PURULENT, NON-ODOROUS DRAINAGE.¿ CULTURES WERE TAKEN. THE CULTURES AND GRAM STAIN WERE NEGATIVE. THE EVENT OUTCOME WAS NOTED AS ¿RESOLVED WITHOUT SEQUELA.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S INCREASED PAIN LED TO AN INTRATHECAL DYE STUDY ON (B)(6) 2014 AT WHICH TIME THE CATHETER COULD NOT BE ASPIRATED; THE CATHETER WAS OCCLUDED. THE DEVICE SYSTEM WAS EXPLANTED AND NOT REPLACED. THE SEVERITY OF THE EVENT WAS NOTED TO BE ¿MODERATE¿. THE OUTCOME WAS NOTED AS ¿ONGOING¿. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF EFFICACY AND STATED THAT THE PUMP ¿FLIPS¿. A POSSIBLE POCKET INFECTION WAS ALSO REPORTED. THERE WAS REPORTED TO BE NO PATIENT INJURY. PHOTOS OF THE PUMP AND CATHETER FOLLOWING EXPLANT SHOW MULTIPLE TWISTS AND A KINK IN THE CATHETER BODY. IT WAS LATER REPORTED THAT THE DEVICE SYSTEM WAS DELIVERING MORPHINE AND CLONIDINE. IT WAS NOTED THAT WHEN THEY TOOK THE PATIENT IN FOR THE CATHETER REPLACEMENT, THERE WAS A CLEAR WHITE MILKY FLUID IN THE POCKET AND THEY DID NOT FEEL IT WAS SAFE TO REIMPLANT AT THIS TIME. THE GRAM STAIN WAS NEGATIVE; THEY WERE AWAITING CULTURE RESULTS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A CLINICAL STUDY REGARDING A PATIENT WITH AN IMPLANTABLE INFUSION PUMP. ACTION WAS TAKEN, NOTED AS "OTHER" ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459934 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention