BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3232498 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11918
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    June 19, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8709 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PUMP WAS EXPLANTED, AFTER JUST THREE MONTHS OF USE, DUE TO INFECTION. THE PATIENT REPORTED THAT SINCE THE INFECTION, HE HAD AN INFLAMMATORY MASS AND FLUID ON HIS BACK. AN ULTRASOUND SHOWED FLUID CORRUGATING IN THE PUMP POCKET AND ALSO ON HIS BACK. THE PATIENT HAD A ¿SPINAL TAP¿ AND REPORTED NO FLUID WAS ABLE TO BE COLLECTED FOR TESTING. THE PATIENT ALSO REPORTED HAVING SYMPTOMS OF STIFF NECK AND SPINAL HEADACHES, IN WHICH HE HAD TWO BLOOD PATCHES FOR. THE PATIENT INDICATED A LUMP WAS STILL PRESENT. THE PATIENT INDICATED, HE ¿THOUGHT¿ HE HAD ¿EITHER VIRAL MENINGITIS OR ENCEPHALITIS.¿ THE PATIENT STATED, ¿I¿M A PARAPLEGIC SO I DON¿T REALLY THINK I MADE A GOOD PATIENT AS FAR AS IN THIS PUMP.¿ THE PATIENT STATED, ¿THINGS ARE JUST GETTING PROGRESSIVELY WORSE.¿ THE PATIENT REPORTED, HE HAD A HERNIA IN HIS STOMACH AND STATED, ¿ I DON¿T KNOW IF IT¿S ASSOCIATED WITH PUMP LEAKAGE OR ANYTHING.¿ THE PATIENT STATED, HE HAS SCAR TISSUE FROM ¿EXPLORATORY SURGERY DOWN MY STOMACH AND THERE¿S A HERNIA AND MY INTESTINES ARE SOME WHAT STICKING OUT BECAUSE, THERE¿S A HOLE THERE.¿ THE PATIENT HAS A HISTORY OF HEADACHES ¿FOR SOME YEARS NOW¿ AND HAS BEEN ¿SCANNED¿ FOR THEM. BECAUSE HIS HEADACHES ARE POSITIONAL, HE HAS TO LAY DOWN FOR THE REST OF THE DAY WHEN HE HAS ONE. THE PATIENT EXPRESSED FRUSTRATION REGARDING HIS HEALTH CARE PROVIDER (HCP) NOT MENTIONING ANYTHING ABOUT PUMP RECALLS, AND OTHER ASSOCIATED RISK FACTORS. THE PATIENT INDICATED ¿A LOT OF INFORMATION WASN¿T GIVEN TO ME AND NOW I¿M SICK.¿ THE PATIENT STATED HIS INFECTION HAS BEEN GOING ON FOR SEVEN MONTHS AND KEEPS ¿COMING UP¿. AT THE TIME OF THIS REPORT, THE PATIENT HAD A TEMPERATURE OF 102.8 FAHRENHEIT, AND STATED, ¿IT CLEARLY HAS SOMETHING TO DO WITH WHAT¿S GOING ON WITH THE PUMP BEING REMOVED AND THE INFECTION.¿ THE PUMP WAS USED TO DELIVER CLONIDINE AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334876 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Required Intervention