BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3142502 · Received June 3, 2013

    Report

    Report Number
    3007566237-2013-01831
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    April 27, 2013
    Report Date
    September 4, 2013
    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

    PRODUCT ID: 8711, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS INFECTION AT THE PUMP IMPLANT SITE. THE DATE OF ONSET WAS (B)(6) 2013. THE DOCTOR WAS CONSIDERING REMOVING THE PUMP AND THE CATHETER. THE PUMP WAS BEING USED TO DELIVER GABALON. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PUMP WAS EXPLANTED. THE PATIENT PRESENTED WITH SKIN SORES AND BEDSORES WHICH WERE CONSIDERED TO HAVE BEEN CAUSED BY THE FACT THAT ¿THE BELT WAS RUBBING THE SKIN¿. THE SORES FORMED ON THE SKIN AROUND THE PUMP AND INFLAMMATION GRADUALLY SPREAD FROM THERE. ORAL ANTIBIOTICS WERE ADMINISTERED. THE DRUG DOSE WAS DECREASED GRADUALLY. THE PATIENT OUTCOME WAS NOTED AS RECOVERED AS OF (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT PRESENTED WITH BEDSORES AS THE PUMP IMPLANT SITE WAS IN A POSITION THAT ¿JUST HIT THE IMPLANT SITE.¿ THE SKIN ON TOP OF THE BELT AND PUMP ¿CHAFED¿ AND CAUSED SORES. THE PATIENT HAD NO SYMPTOMS IN PARTICULAR DURING INFECTION. THE PUMP AND BELT RUBBING AGAINST THE SKIN CAUSED THE SKIN TO BECOME INFLAMED. IT WAS NOTED THE PATIENT¿S ¿C-REACTIVE PROTEIN RETURNED TO NORMAL¿ ON (B)(6) 2013 SO PATIENT ¿DEEMED TO HAVE RECOVERED.¿

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT A REFILL AND DOSE ADJUSTMENT TO 24MCG/DAY FOR TREATMENT OF THE ADVERSE EVENT WAS DONE ON (B)(6) 2013. THE INFECTIONS IMPROVED QUICKLY AFTER REMOVAL OF THE SYSTEM. ON (B)(6) 2012, THE PATIENT¿S C-REACTIVE PROTEIN (CRP) WAS 0.18 MG/DL, ON (B)(6) 2013, IT WAS 0.61MG/DL, AND ON (B)(6) 2013 IT WAS 0.36MG/DL. THE POSSIBLE CAUSES OF THE INFECTION MAY HAVE INCLUDED THE INJECTION PROCEDURE, VITAL RESISTANCE, AND DECLINE IN IMMUNITY AND FOREIGN BODY REACTION. THE EVENT WAS REPORTED TO BE RELATED TO THE PUMP AND NOT RELATED TO THE CATHETER, PROGRAMMER, PROCEDURE OR DRUG.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE DATE OF ONSET WAS 2013-(B)(6).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE INFECTION HAD OCCURRED THREE YEARS AFTER IMPLANT. THE POSSIBLE CAUSES WERE ¿METHOD OF INJECTION, LOWERING OF THE RESISTING POWER AND THE IMMUNITY STRENGTH, FOREIGN BODY REACTION ETC.¿ THE INFECTION IMPROVED RAPIDLY AFTER REMOVING THE PUMP SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244507 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