BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3133738 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08306
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    July 19, 2017
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LUMBAR HEMATOMA. AN MRI WAS PERFORMED ON (B)(6) 2013. THEY EVACUATED THE HEMATOMA T12-L1 ON (B)(6) 2013. THE PATIENT¿S SYMPTOMS INCLUDED RESIDUAL LEFT LEG WEAKNESS AND NUMBNESS AS WELL AS AN UNSTEADY GAIT. THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2013. IT WAS NOTED THAT IT WAS NOT RELATED TO THE DEVICE OR THERAPY, AND POSSIBLY RELATED TO THE IMPLANT PROCEDURE. THE MEDICATIONS USED WITHIN THE SYSTEM WERE FENTANYL, DILAUDID, AND BUPIVACAINE. IT WAS LATER REPORTED THAT THE HEMATOMA WAS NOTED AS A INTRASPINAL LUMBAR HEMATOMA. IT WAS LATER REPORTED THAT AS OF (B)(6) 2013 THE PATIENT HAD RESIDUAL NUMBNESS THOUGH ¿SENSATION WAS RETURNING¿. THE PATIENT WAS ALSO NOTED TO BE UNABLE TO WALK. THE MRI PERFORMED ON (B)(6) 2013 INDICATED THAT THE INTRATHECAL CATHETER TIP WAS SITUATED IN THE DORSAL SUBARACHNOID SPACE AT T7 WITHOUT EVIDENCE FOR GRANULOMAS. A DORSAL EPIDURAL MASS AT L1 WAS NOTED.

    Description of Event or Problem · 1

    ONE MONTH LATER, IT WAS REPORTED THAT THE PATIENT STILL HAD RESIDUAL LEFT LEG NUMBNESS. THE PATIENT¿S SYMPTOMS INCLUDED AN UNSTEADY GAIT AND RESIDUAL LEFT LEG NUMBNESS FOLLOWING THE EVACUATION OF THE INTRASPINAL LUMBAR HEMATOMA.

    Description of Event or Problem · 1

    CORRECTION ¿ THE EVENT RESULTED IN IN-PATIENT OR PROLONGED HOSPITALIZATION. THE PATIENT¿S SYMPTOMS INCLUDED UNSTEADY GAIT. PHYSICAL THERAPY WAS PRESCRIBED AS OF (B)(6) 2013. THE PATIENT¿S OUTCOME WAS NOTED AS ¿ONGOING EVENT¿.

    Description of Event or Problem · 1

    THE EVENT WAS LATER NOTED TO BE ¿ONGOING WITH NO FURTHER ACTION NEEDED¿.

    Description of Event or Problem · 1

    ON (B)(6) 2017, ADDITIONAL INFORMATION WAS RECEIVED FROM AN HEALTHCARE PROFESSIONAL (HCP) VIA AN ISPR UPDATE. THE ADVERSE EVENT WAS UPDATED FROM "LUMBAR HEMATOMA - INTRASPINAL" TO "HEMATOMA AT IMPLANT SITE; INTRASPINAL LUMBAR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235411 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Hospitalization| R| S