BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4121039 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17785
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS FURTHER PROVIDED THAT PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED. THE ONSET OF THE INFECTION WAS ONE TO TWO WEEK AFTER IMPLANT. THE PATIENT EXPERIENCED A FEVER, REDNESS, SWELLING, PAIN, AND REPORTEDLY (B)(6) SIGNS/SYMPTOMS. THE LOCATION OF THE INFECTION WAS REPORTED AS THE DEVICE POCKET AND LUMBAR REGION. A CULTURE WAS TAKEN OF THE DEVICE POCKET AND (B)(6) WAS NOTED. IN ADDITION TO THE SYSTEM EXPLANT THE PATIENT ALSO REQUIRED ORAL AND INTRAVENOUS ANTIBIOTICS. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED AT THE TIME OF THE EVENT, THE PATIENT WAS NOT DIAGNOSED WITH MENINGITIS. THE PUMP HADN'T BEEN REFILLED SINCE IMPLANT. THE DEVICE MANUFACTURER REPRESENTATIVE DIDN'T KNOW THE TYPE OF ORGANISM CULTURED OR WHEN THE INFECTION ONSET/WAS DIAGNOSED. THE PUMP WAS TAKEN TO THE HOSPITAL LAB AND THE HOSPITAL WAS IN POSSESSION OF THE DEVICE. PER THE HEALTH CARE PROVIDER (HCP), THE INFECTION RESOLVED AND NO FURTHER INFORMATION WAS DISCLOSED ON THE PATIENT'S CONDITION OR MEDICATIONS THE PATIENT WAS ON AT THE TIME OF THE INFECTION. ADDITIONAL INFORMATION REGARDING THE EVENT INCLUDING THE ONSET/DIAGNOSIS DATE OF THE INFECTION AND THE TYPE OF ORGANISM CULTURED HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION OF AN UNKNOWN TYPE ALONG WITH SWEATING/DIAPHORESIS. THE LOCATION OF ISSUE OR SYMPTOMS WAS REPORTED AS THE DEVICE POCKET. CULTURES WERE TAKEN FROM THE DEVICE POCKET AND LUMBAR REGION. THIS REQUIRED THE PATIENT TO RECEIVE ANTIBIOTIC TREATMENT AND THE EXPLANTED OF BOTH THE CATHETER AND THE PUMP. NEW PRODUCTS WERE TO BE IMPLANTED AT A LATER DATE. NO DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS PERFORMED AND THE CAUSE OF THE ISSUE WAS UNKNOWN. THERE WERE NO ALLEGED PRODUCT ISSUES OF THE PUMP OR CATHETER. AT THE TIME OF THE REPORT THE PATIENT'S STATUS WAS REPORTED AS ALIVE-NO INJURY. THIS DEVICE SYSTEM DELIVERED INFUMORPH. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED AND A REQUEST WAS MADE TO DETERMINE THE PATIENT¿S OUTCOME. HOWEVER, NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601688 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention