BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4624982 · Received March 23, 2015

    Report

    Report Number
    3004209178-2015-05256
    Event Type
    Injury
    Date Received
    March 23, 2015
    Report Date
    March 13, 2015
    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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER; PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER; PRODUCT ID 8590-9, LOT# N213886, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY; PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A DYE STUDY WAS PERFORMED ON (B)(6) 2015, AND THE DOCTOR NOTICED A BLOOD IN THE FLUID SINCE IT HAD A RED TINGE. THE PATIENT STATED THE DOCTOR HAD ALREADY CONFIRMED THAT THERE WAS AN OBSTRUCTION IN THE CATHETER. THE PATIENT STATED THAT ON THE NIGHT AFTER THE DOCTOR PERFORMED THE DYE STUDY PROCEDURE ON THEM, THEY HAD A LUMP OF FLUID THAT NIGHT. THE PATIENT TOOK A ROUND OF ¿CIPRO¿ AND THE LUMP WENT AWAY. THE PATIENT WAS SCHEDULED FOR A PUMP AND CATHETER REPLACEMENT ON (B)(6) 2015, BUT IT WAS CANCELLED BY THE PHYSICIAN. THEY WERE TENTATIVELY RESCHEDULED FOR (B)(6) 2015. THE PUMP CONTAINED DILAUDID AND MORPHINE.

    Description of Event or Problem · 1

    AS OF THE DATE OF THIS REPORT, NOTHING HAD BEEN DONE WITH THE PATIENT; THE PATIENT'S SURGERY WAS NOT YET SCHEDULED.

    Description of Event or Problem · 1

    PER THE PATIENT, THE EVENT DATE WAS 2014. THE CATHETER KEPT KINKING AND THEY NEVER FIGURED OUT WHY. THE PATIENT HAD LOST 100 LBS AND HE THOUGHT SOMETHING HAPPENED WHEN HE GAINED IT BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192622 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention