BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2704293 · Received August 17, 2012

    Report

    Report Number
    3004209178-2012-07018
    Event Type
    Injury
    Date Received
    August 17, 2012
    Date of Event
    May 16, 2012
    Report Date
    July 25, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-2380-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8591-38, LOT # D17878, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY. A PARTIAL CATHETER WAS RETURNED. ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE CATHETER FOUND THAT THE SUTURELESS CONNECTOR (SC) HAD AN INDENT IN THE SEAL. UNDER MICROSCOPE INSPECTION A CIRCULAR INDENT CAN BE SEEN IN THE BOTTOM OF THE CUP OF THE SC CONNECTOR CONSISTENT WITH THE INNER DIAMETER OF THE TIP OF THE OUTLET PORT OF THE PUMP. A SIGNIFICANT MAJORITY OF THE INDENT IS LOCATED IN THE SILICONE MATERIAL OF THE CUP OF THE SC CONNECTOR. THIS INDICATES THE CONNECTION BETWEEN THE SC CONNECTOR AND THE PUMP'S OUTLET PORT MAY POSSIBLY HAVE BEEN OCCLUDED. EVAL CODE CONCLUSION: 11 UPDATED TO 77.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS REPLACED DUE TO AN OCCLUSION AT THE SUTURELESS CONNECTION (SC). A DYE STUDY WAS PERFORMED AND THE PHYSICIAN COULD NOT ASPIRATE THE CATHETER. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL (BACLOFEN). NO PATIENT SYMPTOMS OR INJURY WERE REPORTED. THE PATIENT OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELA. 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 II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention