BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2251569 · Received September 14, 2011

    Report

    Report Number
    3004209178-2011-07822
    Event Type
    Injury
    Date Received
    September 14, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 7, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PREVIOUSLY REPORTED "OUTCOME ATTRIBUTED TO ADVERSE EVENT" OF "CONGENITAL ANOMALY/BIRTH DEFECT" WAS REPORTED IN ERROR. IT DOES NOT APPLY TO THIS EVENT. PRODUCT ID, 8835 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    CATHETER MODEL 8709SC, LOT# N285267008, EXPLANTED: 2011-(B)(6). CORRECTED THE CATHETER EXPLANT DATE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT EXPERIENCED A FEVER AND A WOUND INFECTION. NO FURTHER DETAILS WERE PROVIDED. THERE WAS NO INFORMATION PROVIDED RELATED TO THE INFECTION-CAUSING ORGANISM. AS NOTED ON 2011-(B)(6), THE PATIENT'S PUMP DID NOT USE EITHER LIORESAL OR INFUMORPH (COMPOUNDED BACLOFEN OR MORPHINE SULFATE). IT WAS FURTHER NOTED THAT THE CAUSE OF THE REPORTED EVENT WAS NOT RELATED TO THE DEVICE, THERAPY, OR IMPLANT PROCEDURE. THE PATIENT WAS REPORTED TO HAVE RESOLVED WITHOUT SEQUELAE ON 2012-(B)(6).

    Description of Event or Problem · 1

    SPINAL FLUID LEAK WAS REPORTED. IT WAS STATED THAT ON "(B)(6) 2011 PT CAME TO OFFICE FOR A VISIT AND COMPLAINED OF SPINAL HEADACHE AND THE PHYSICIAN NOTICED SPINAL FLUID LEAK." A (B)(6) STUDY DONE ON (B)(6) WAS NORMAL. BLOOD PATCH WAS DONE AND THE FLUID LEAK STOPPED. PT WAS HOSPITALIZED AND IT WAS NOTED AS "PROLONGED EXISTING HOSPITALIZATION." SURGICAL OBSERVATION CONCLUDED LEAK AROUND THE CATHETER ON (B)(6) 2011. A REPAIR OF WOUND WAS DONE ON (B)(6). CATHETER WAS EXPLANTED ON (B)(6) 2011. EVENT OUTCOME WAS REPORTED AS "ONGOING". DRUG DELIVERED VIA THE DEVICE WAS MORPHINE 5.0 MG/DL AT 0.9992 MG/DAY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT A POSSIBLE WOUND INFECTION WAS FOUND ON (B)(6) 2011. IT WAS NOTED THAT ON (B)(6) 2011, THE PATIENT'S WOUND WAS DEBRIDED IN THE BACK, THE CATHETER WAS EXPLANTED, AND THE PUMP WAS STOPPED. IT WAS ALSO REPORTED THAT DURING THE MIDLINE WOUND REVISION ON (B)(6) 2011, THE INTRATHECAL CATHETER WAS REANCHORED, AND EVICEL WAS APPLIED TO REINFORCE CLOSURE OF THE WOUND. IT WAS UNCLEAR IF THE CATHETER WAS ENTIRELY EXPLANTED OR PARTIALLY REVISED. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF FURTHER INFORMATION IS RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Congenital Anomaly| H| R EXPLANTED:| PROGRAMMER: MODEL 8835, LOT# NPG023746N| CATHETER: MODEL 8709SC, LOT# N285267008| IMPLANTED: