BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3813087 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-09027
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    January 24, 2014
    Report Date
    April 14, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8782, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER; PRODUCT ID 8781, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD ¿HAD LIKE 8 CSF LEAKS IN 40 DAYS¿ SINCE THE TIME OF IMPLANT IN (B)(6). WHEN THEY TOOK THE STAPLES OR STITCHES OUT IT WOULD ¿BUST OPEN¿ AND THE PATIENT WOULD HAVE A CSF LEAK. THE PATIENT HAD ¿LIKE 8 SURGERIES IN 42 DAYS¿. THE DEVICE SYSTEM HAD DELIVERED FENTANYL, BUPIVACAINE, BACLOFEN, AND MORPHINE SINCE IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED 7 DAYS AFTER THE REVISION PROCEDURE, THEY WENT TO TAKE THE STAPLES OUT AND "IT EXPLODED ON MY BACK." THE PATIENT WENT IN FOR SURGERY 6 TIMES IN A 51 DAY PERIOD BECAUSE "HE [COULD NOT] FIX MY BODY FROM LEAKING SPINAL FLUID." IT WAS STATED THIS REPEATED SEVERAL TIMES, BUT HAD NOW BEEN RESOLVED. THE PUMP WAS INFUSING MORPHINE AND BACLOFEN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER. IT WAS REPORTED THE PATIENT HAD "4" CEREBROSPINAL FLUID (CSF) LEAKS BETWEEN (B)(6) 2013 THROUGH (B)(6) 2014. THE PATIENT'S ¿OLD¿ DRUGS WERE LISTED AS UNKNOWN BACLOFEN 100 MCG/ML (DOSE 54.03 MCG/DAY) AND MORPHINE (UNKNOWN CONCENTRATION AND DOSE). NO FURTHER INFORMATION RELATED TO THE EVENT WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER. THE PUMP WAS IMPLANTED DUE TO "CAR ACCIDENTS". AFTER THE PUMP AND CATHETER WERE IMPLANTED, THE PATIENT NEEDED TO HAVE A CATHETER REVISION AND HAD 7 SURGERIES IN 40 DAYS AFTER INITIAL DEVICE IMPLANT SURGERY. FROM (B)(6) 2013 TO (B)(6) 2014 WAS THE TIME FRAME THE SURGERIES OCCURRED. THE PATIENT'S STITCHES OPENED UP MANY TIMES AND SHE HAD ISSUES WITH SPINAL FLUID LEAKS. THE PATIENT HAD A "SPINAL DRAIN DRIP". THE PATIENT'S SPINAL FLUID WAS LOWERED AND SHE HAD TO LAY THERE IN BED FOR MANY DAYS TO LET THE SITE HEAL ON ITS OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290870 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Required Intervention