BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2032509 · Received March 23, 2011

    Report

    Report Number
    3004209178-2011-02210
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 17, 2011
    Report Date
    March 14, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DEVICES HAVE BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    AFTER PUMP IMPLANT, THE PATIENT'S WOUND DEHISCED. THE WOUND WAS TREATED, ANTIBIOTICS WERE GIVEN, BUT THE WOUND GOT WORSE. THE PATIENT WAS GETTING GOOD RELIEF FROM THE PUMP, BUT HAD OTHER HEALTH ISSUES (DIABETES AND CONGESTIVE HEART FAILURE). THE PUMP AND CATHETER WERE REMOVED; THE DISTAL PIECE OF THE SPINAL SEGMENT WAS SENT FOR CULTURE AND THE PUMP POCKET WAS CULTURED. IT WAS UNKNOWN IF AN INFECTION WAS PRESENT OR NOT OR IF THERE WAS JUST THE FEAR OF INFECTION THAT PROMPTED THE REMOVAL OF THE PUMP. THERE WAS REPORTED TO BE NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID 10 MG/ML AT 2.764 MG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8598, LOT# N001981316| CATHETER: MODEL 8711, LOT# J11414R47| EXPLANTED:| EXPLANTED:| IMPLANTED: