BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4222230 · Received November 3, 2014

    Report

    Report Number
    3004209178-2014-20882
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8780, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER; PRODUCT ID 8835, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS FLIPPED AND CONFIRMED. A DYE STUDY WAS DONE. THE PATIENT FELL THEN SUTURES POPPED LOOSE REQUIRING SURGERY TO TIE DOWN. THEY WENT INTO REVISE AND SECURE THE PUMP DOWN IN THE POCKET AND WHEN TRYING TO ASPIRATE FROM THE CAP, THEY WERE UNABLE TO ASPIRATE OR PUSH ANYTHING THROUGH. THE HCP THEN CUT THE CATHETER AT THE PIN CONNECTOR SITE AND GOT GREAT CSF FLOW FROM THAT LOCATION. THE PHYSICIAN ASSUMED THE ISSUE WAS WITH CONNECTION. THEY EXPLANTED PUMP CONNECTOR AND CATHETER CONNECTOR AND REPLACED. THE PATIENT'S STATUS AT THE TIME OF REPORT WAS "ALIVE-NO INJURY." ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PUMP WAS FUNCTIONING NORMALLY WITHOUT ANY ISSUES. IT HAD NOT BEEN CONFIRMED THAT THE CATHETER ISSUE INVOLVED THE CONNECTOR PIN. IT WAS UNKNOWN HOW THE PATIENT WAS DOING AND IF THEY WERE RECEIVING EFFECTIVE THERAPY. NO PATIENT SYMPTOMS WERE REPORTED TO BE RELATED TO THIS EVENT. THE PUMP SYSTEM WAS DELIVERING DILAUDID. (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).

    Description of Event or Problem · 1

    IT WAS NOTED THAT THEY WERE UNABLE TO READ THE PUMP WITH THE PTM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702875 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Required Intervention