BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2840108 · Received November 20, 2012

    Report

    Report Number
    3004209178-2012-10563
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    September 20, 2012
    Report Date
    October 23, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# (B)(4), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT EXPERIENCED PUMP EXTRUSION FOR A SECOND TIME. PUMP EXTRUSION WAS OBSERVED AT THE PATIENT¿S HOME (B)(6) 2012. ON (B)(6) 2012 THE PATIENT VISITED AND WAS ADMITTED TO THE HOSPITAL WHERE HIS PUMP WAS REMOVED. IT WAS NOTED THE EXTRUSION WAS NOT DRUG, DEVICE, OR PROCEDURE RELATED. IT WAS ALSO NOTED THE PATIENT HAD EXPERIENCED PUMP EXTRUSION IN SEPTEMBER, AS PREVIOUSLY REPORTED IN MFR REPORT 3004209178-2012-10563. IT WAS REITERATED THE ¿PATIENT SUFFERED FROM OBESITY, HENCE PRESSURE WAS PROBABLY APPLIED TO THE PUMP IMPLANTED SITE BY THE PATIENT¿S ABDOMINAL SHAPE AND BY THE PATIENT¿S SPASMING, WHICH RESULTED IN PUMP EXTRUSION (SAME AS WITH THE PREVIOUS CASE).¿ IT WAS NOTED THE SUBSEQUENT TREATMENT POLICY WAS UNDER CONSIDERATION. ADDITIONAL INFORMATION RECEIVED REPORTED THE FIRST TIME THE PATIENT EXPERIENCED PUMP EXTRUSION IN SEPTEMBER THE PATIENT WAS ADMINISTERED VICCILLIN INTRAVENOUSLY (B)(6) 2012. IT WAS NOTED AFTER THE SECOND EXTRUSION EVENT THE PATIENT HAD MULTIPLE GABALON DOSE CHANGES, THE FINAL REPORTED DAILY DOSE WAS 76 MICROGRAMS CHANGED ON (B)(6) 2012. IT WAS ALSO NOTED THE PATIENT WAS ADMINISTERED INTRAVENOUS CEFAMEZIN ON (B)(6) 2012 AND HE WAS ADMINISTERED ORAL LIORESAL (B)(6) 2012. IT WAS CLARIFIED THE PATIENT¿S DEVICE WAS REMOVED (B)(6) 2012 ¿IN CONSIDERATION OF THE FACT THE LOCAL INFECTION MAY SPREAD SYSTEMICALLY.¿ IT WAS NOTED AS OF (B)(6) 2012 THE PATIENT¿S SYMPTOMS WERE IMPROVING. IT WAS ALSO NOTED ¿AN EFFECT OF THE PREVIOUS PUMP EXTRUSION WAS TO SLOW DOWN THE SURGICAL WOUND¿S NATURAL HEALING PROCESS. IN ADDITION, IT WAS EVALUATED THAT OBESITY ALSO CONTRIBUTED TO THE OCCURRENCE OF A SECOND EXTRUSION.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PUMP EXTRUSION WAS OBSERVED. THE EVENT WAS NOT RELATED TO DRUG, PUMP, CATHETER, PROGRAMMER, OR PROCEDURE. REDDENING WAS OBSERVED AT THE PUMP IMPLANTATION SITE WHEN THE PATIENT VISITED THE HOSPITAL. THE PUMP WAS EXTRUDED, WITH A SECTION OF THE PUMP EXPOSED. DOSE CHANGE, DEBRIDEMENT, POCKET ENLARGEMENT AND RE-IMPLANTATION WERE ALL PERFORMED. VICCILLIN S1000 WAS INJECTED FOR THE ADVERSE EVENT. THE PUMP POCKET WAS CLEANED AND "REPEATED TO ADEQUATE LEVELS." THEN THE PUMP POCKET "EXTENDED DOWNWARD" AND IT WAS RE-SECURED. THE PATIENT SUFFERED FROM OBESITY, HENCE THERE WAS PROBABLY PRESSURE APPLIED TO THE PUMP IMPLANTATION SITE BY THE PATIENT'S ABDOMINAL SHAPE AND BY THE PATIENT'S "SPASMING", WHICH RESULTED IN PUMP EXTRUSION. THE PATIENT'S CONDITION WAS NOTED AS "IMPROVING." THE PATIENT OUTCOME WAS UNKNOWN. THE DEVICE WAS USED TO DELIVER BACLOFEN (GABALON).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Required Intervention