BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2973893 · Received February 22, 2013

    Report

    Report Number
    3007566237-2013-00569
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 1, 2013
    Report Date
    October 15, 2019
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED FOLLOWING A CATHETER REVISION FOR POCKET CEREBROSPINAL FLUID (REFER TO MANUFACTURER REPORT # 3007566237-2012-03055), THE PATIENT RETURNED ON (B)(4) 2012 WITH A POCKET SEROMA. THROUGHOUT (B)(6) 2013, WHILE THE POCKET WAS TREATED (DRAIN, ANTIBIOTICS) THE INTRATHECAL BACLOFEN WAS GRADUALLY TITRATED DOWN IN CASE IT BECAME NECESSARY TO REMOVE THE PUMP. THE TITRATION WAS TOLERATED WELL BY THE PATIENT USING ORAL MEDICATION REPLACEMENT. THE PUMP WAS THEN EXPLANTED. THE PATIENT WAS SEEN IN FOLLOW-UP BY THE NEUROSURGEON ON (B)(6) 2013. AT THAT TIME IT WAS REPORTED THE POCKET WAS NOT YET HEALED AND IT CONTINUED TO LEAK SOME ELEMENT OF SEROSANGUINOUS FLUID. IT WAS NOTED THERE WAS NO EVIDENCE OF A WOUND INFECTION AT THAT TIME. ONGOING TREATMENT AND FOLLOW-UP BY THE NEUROSURGEON OCCURRED. IT WAS REPORTED THERE WAS NO PLAN TO RE-IMPLANT AT THAT TIME HOWEVER POSSIBLY IN THE FUTURE. IT WAS LATER REPORTED THE PATIENT WAS STILL WITHOUT A PUMP. AS OF THE PATIENT¿S LAST FOLLOW UP WITH NEUROSURGERY, THE WOUND HAD HEALED AND THE PATIENT WAS OFF ANTIBIOTICS. THE PATIENT WAS DOING RELATIVELY WELL ON ORAL MEDICATIONS THOUGH THE PATIENT¿S FAMILY REPORTED THAT SPASTICITY MANAGEMENT WAS BETTER WITH THE PUMP. THE POSSIBILITY OF A PUMP REPLACEMENT WAS TO BE DISCUSSED LATER IN THE YEAR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT ON (B)(6) 2013, THE PATIENT WAS BEING EVALUATED FOR REMOVAL OF STITCHES AFTER A POCKET EVACUATION FOR SEROMA (AS PREVIOUSLY REPORTED) AND THE PATIENT WAS SUBSEQUENTLY ADMITTED TO AN IN-PATIENT UNIT WITH A FEVER ¿SINCE THE PREVIOUS EVENING" AND "TWO SMALL AREAS OF REDNESS, BEYOND WHAT THE HCP WOULD ATTRIBUTE TO HEALING ALONE". THREE CC¿S OF FLUID WERE ASPIRATED FROM THE POCKET AND SENT FOR A GRAM STAIN WHICH SHOWED ¿A FEW COCCHI AND A FEW PUS CELLS". ON (B)(6) 2013, IT WAS NOTED THE PATIENT WAS ON KEFLEX FOR HIS STAPH AUREUS INFECTION. ON (B)(6) 2013 DURING THE CLINIC FOLLOW-UP POST PUMP REMOVAL THERE WAS NO DISCHARGE OR OTHER SENSE OF INFECTION; NO SYSTEMIC FEVER; AND THE PLAN FOR THE PATIENT WAS TO "FINISH PRESENT ANTIBIOTIC COURSE AND THEN CAN STOP TAKING IT".

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED PRIOR TO THE PUMP EXPLANT, THE PATIENT¿S INTRATHECAL BACLOFEN DOSE WAS GRADUALLY TITRATED THROUGHOUT (B)(6) 2013 DOWN AND WAS TOLERATED WELL BY THE PATIENT USING ORAL MEDICATION REPLACEMENT. WHEN THE PATIENT WAS SEEN FOR A FOLLOW UP APPOINTMENT WITH THE NEUROSURGEON ON (B)(6) 2013, IT WAS NOTED THERE WAS NO EVIDENCE OF WOUND INFECTION AT THAT TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED AN INFECTION OCCURRED. THE PUMP POCKET WAS FOUND TO BE INFECTED AND THE HEALTH CARE PROVIDER (HCP) HAD BEEN "DRAWING DOWN" THE DOSE IN THE PUMP ANTICIPATION OF POSSIBLY REMOVING THE PUMP. THE PATIENT HAD BEEN TRANSITIONED TO A HIGH DOSE OF ORAL BACLOFEN AND THE INTRATHECAL LIORESAL DOSE HAD BEEN DROPPED. IT WAS NOTED THE PATIENT HAD CEREBRAL PALSY AND HAD A PUMP FOR EIGHT TO NINE YEARS. THE HCP DISCUSSED PROGRAMMING THE PUMP TO MINIMUM RATE MODE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78459 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other| R