BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3212379 · Received July 9, 2013

    Report

    Report Number
    3004209178-2013-11472
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    June 17, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. PRODUCT ID: 8590-1, LOT# N286615, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO ANOMALY, NORMAL DEVICE FUNCTION. NO ANOMALIES NOTED IN PUMP LOGS.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ACCESSORY MODEL 8590-1, LOT# N286615, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013. CATHETER MODEL 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2013. (B)(4). THE PUMP HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    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 EXPERIENCED A DECREASE IN THERAPY EFFICACY; THE PATIENT HAD INCREASED SPASTICITY. AN INDIUM STUDY SHOWED NO DRUG GETTING PAST PUMP/CATHETER CONNECTION. IT WAS RECOMMENDED THAT PATIENT HAVE BOTH THE PUMP AND CATHETER CHANGED BECAUSE THE PHYSICIAN COULD NOT PINPOINT WHERE THE ISSUE WAS. IN THE OR (OPERATING ROOM), UPON OPENING THE PUMP POCKET, THE PATIENT WAS FOUND TO HAVE A POCKET FILLED WITH A COPIOUS AMOUNT OF THICK YELLOW FLUID. AN INFECTION WAS SUSPECTED. THE POCKET WAS CULTURED FOR INFECTION. THE POCKET WAS IRRIGATED AND CLEANED. ALL PRODUCTS WERE EXPLANTED. ANTIBIOTICS AND ORAL BACLOFEN WERE STARTED. RE-IMPLANT WAS PLANNED WHEN THE PATIENT WAS HEALED AND INFECTION FREE. THE PATIENT STATUS WAS REPORTED TO BE ¿ALIVE - NO INJURY/NO ADVERSE EVENT¿. THE PUMP WAS DELIVERING GABLOFEN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE SYSTEM WAS USED TO INFUSE COMPOUNDED BACLOFEN. PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED. THE TREATMENT INCLUDED ORAL ANTIBIOTICS. THE ONSET/DIAGNOSIS OF THE INFECTION WAS (B)(6) 2013, THE SYMPTOMS INCLUDED INCISIONAL WOUND OPENING. THE PRIMARY LOCATION OF INFECTION WAS THE DEVICE POCKET; CULTURE OBTAINED FROM DEVICE POCKET, THE TYPE OF ORGANISM WAS UNKNOWN. THE PATIENT DID NOT HAVE MENINGITIS. THE LAST REFILL DATE WAS UNKNOWN. PATIENT OUTCOME WAS NOTED AS INFECTION RESOLVED. IT WAS NOTED THAT THE RISK FACTOR THAT APPLIED TO THE PATIENT PRIOR TO IMPLANTATION OF THE DEVICE WAS "DEBILITATED STATUS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313165 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R