BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4131314 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18030
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 22, 2014
    Report Date
    June 16, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT TREATMENT INCLUDED BOTH IV AND ORAL ANTIBIOTICS. THE TYPE OF ORGANISM CULTURED WAS UNKNOWN. THE PATIENT'S INFECTION RESOLVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE WAS EXPLANTED ON (B)(6) 2014 DUE TO AN INFECTION. THE PATIENT REQUESTED THE SMALLER PUMP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INFECTION. THE ACTIONS REQUIRED AS A RESULT OF THE EVENT INCLUDED EXPLANT OF THE PUMP AND CATHETER ON (B)(6) 2014. DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS NOT PERFORMED AS IT WAS NOT REQUIRED. PATIENT DEVELOPED WOUND DEHISCENCE, DRAINAGE/INCISIONAL WOUND OPENING AT PUMP POCKET WHICH REQUIRED PUMP EXPLANT. AT THE TIME OF REPORT THE PATIENT¿S STATUS WAS ALIVE ¿ NO INJURY. THE PUMP WAS USED TO INFUSE MORPHINE. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610558 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention