BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2704808 · Received August 17, 2012

    Report

    Report Number
    3004209178-2012-07056
    Event Type
    Injury
    Date Received
    August 17, 2012
    Report Date
    July 25, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, LOT# J10841R40, SERIAL# IMPLANTED: (B)(6) 2001, EXPLANTED: PRODUCT TYPE CATHETER PRODUCT ID 8575, LOT# N132719, SERIAL# IMPLANTED: (B)(6) 2008, EXPLANTED: PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE 'MOST RECENT RECURRENCE' OF INFECTION OCCURRED ON (B)(6) 2012. THE PATIENT'S SYMPTOMS WERE REDNESS, SWELLING, DRAINAGE, PAIN, AND INCISIONAL WOUND OPENING. THE SYMPTOMS WERE LOCATED IN THE DEVICE POCKET. CULTURES OF INFECTED AREA SHOWED THAT THE BACTERIA PRESENT WERE "PROTEUS MIRABILIS/DIPHTEROIDS". CULTURES WERE NEGATIVE FOR (B)(6). THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS, ORAL ANTIBIOTICS, AND WOUND VACUUM-ASSISTED CLOSURE (VAC). THE PUMP WAS ALSO EXPLANTED. THE RISK FACTORS THAT APPLIED BEFORE SURGERY WERE "DEBILITATED STATUS [WITHOUT] TRAUMA," AND THE CURRENT STATUS OF THE PATIENT'S INFECTION AT THE TIME OF REPORT WAS "ONGOING."

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS CLARIFIED THAT PATIENT HAD INFECTION IN (B)(6) 2012 WHEN THE PREVIOUS PUMP WAS EXPLANTED AND THIS HAS BEEN REPORTED IN MFR REPORT # 3004209178-2012-07728. IN REGARDS THIS EVENT PATIENT HAD RECURRENCE OF INFECTION ON (B)(6) 2012 AS REPORTED PREVIOUSLY. PER THE HCP THE PUMP WAS EXPLANTED "BECAUSE OF THE SAME INFECTION". THEY EXCISED THE ABUNDANCE OF SCAR TISSUE AND REMOVED THE PUMP. THE PATIENT WAS STILL RECEIVING WOUND CARE BUT HAD NOT BEEN BACK TO SEE THE HCP. THERE WERE NO PLANS TO PLACE ANOTHER PUMP IN THIS PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH A SUBCUTANEOUS INFECTION. THE PUMP AND CATHETER WERE TO BE EXPLANTED DUE TO THE INFECTION; HOWEVER, REMOVAL HAD NOT YET TAKEN PLACE. IT WAS DENIED THAT THE PATIENT WAS WEANED OFF OF THE INTRATHECAL MEDICATION. THE PHYSICIAN WASTED TO START THE PATIENT ON ORAL MEDICATION. THE DEVICE SYSTEM WAS USED TO DELIVER CLONIDINE AND DILAUDID (HYDROMORPHONE). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention