BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 2052643 · Received April 7, 2011

    Report

    Report Number
    6000030-2011-02667
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    January 1, 2003
    Report Date
    July 9, 2024
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT A DYE STUDY WAS PERFORMED APPROXIMATELY SEVEN MONTHS AFTER IMPLANT AND IT WAS DISCOVERED THAT THERE WAS A TEAR IN THE CATHETER AND THERE WAS A SURGICAL REVISION TO REPAIR IT. THE REPORTER STATED THAT 10 DAYS AFTER THEIR REVISION THEY BECAME ILL. THEN ONE TO TWO MONTHS LATER, ANOTHER DYE STUDY WAS PERFORMED AND IT WAS FOUND THAT THE MEDICATION WAS NOT GOING INTO THE CATHETER; THEREFORE, ANOTHER REVISION WAS PERFORMED.

    Description of Event or Problem · 1

    THE CATHETER PUNCTURED AND HAD A RIP IN IT. TWO REVISION SURGERIES WERE DONE RELATED TO THAT CATHETER. THE PATIENT HAD 3 CATHETERS. IT IS UNCLEAR WHICH DEVICE WAS ASSOCIATED WITH THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MANUFACTURING 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention "SEE H11...."| CATHETER: MODEL 8709, LOT# J11310R55| CATHETER: MODEL 8709, LOT# J11527R13| CATHETER: MODEL 8709, LOT# J11594R49| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# J11594R49| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709, LOT# J11310R55| CATHETER: MODEL 8709, LOT# J11527R13| EXPLANTED: