BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3973598 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-13836
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    March 24, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT HAD ¿FLOWING¿ ON THE SCAR WITHOUT FEVER AND REDNESS. PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT WERE REPORTED AS PROCEDURE RELATED. THE PATIENT REQUIRED AN URGENT CARE VISIT AND ON (B)(6) 2014, ANTIBIOTICS WERE PROVIDED. ON (B)(6) 2014, EXAMINATION REVEALED REDNESS AND WARMTH AROUND THE SCAR AND ¿YELLOW FLOWING¿. THE EVENT SEVERITY WAS CHARACTERIZED AS MODERATE. SUBSEQUENTLY, THE DECISION TO EXPLANT ALL OF THE ¿SYSTEM¿ WAS MADE DUE TO RISK OF INFECTION ON THE ¿LCR¿; AND THE ¿SYSTEM¿ WAS EXPLANTED AND NOT REPLACED. THE PUMP WAS EXPLANTED ON (B)(6) 2014, BUT THE CATHETER REMAINED IMPLANTED AND IN SERVICE, AND THE LOCATION OF THE ISSUE OR SYMPTOM WAS SPECIFIED AS THE DEVICE POCKET. THE OUTCOME WAS REPORTED AS RESOLVED WITHOUT SEQUELA AS OF (B)(6) 2014. THE MEDICATION IN THE PUMP WAS NOT SPECIFIED. IT WAS LATER REPORTED THAT ¿FLOWING¿ ON THE SCAR REFERRED TO LIQUID AROUND THE SCAR. IT WAS NOTED THAT A CULTURE AT THE SCAR SITE WAS NOT INDICATED. THE PUMP WAS BEING USED TO INFUSE CLONIDINE AND HYDROMORPHONE.

    Description of Event or Problem · 1

    IT WAS FURTHER PROVIDED THE CLINICAL DIAGNOSIS WAS DRAINAGE FROM THE WOUND. THE EVENT RESULTED IN A SERIOUS DETERIORATION IN THE HEALTH OF THE PATIENT AND RESULTED IN IN-PATIENT OR PROLONGED HOSPITALIZATION AND THE ADMINISTRATION OF ANTIBIOTICS. THIS WAS REPORTED AS RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449780 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R