BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1901951 · Received November 12, 2010

    Report

    Report Number
    3004209178-2010-09429
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    September 1, 2010
    Report Date
    December 14, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT. ANALYSIS OF THE PUMP REVEALED NO ANOMALY FOUND; NORMAL DEVICE FUNCTION. THE CATHETER WAS RECEIVED IN 4 PIECES. ALL PIECES PASSED PATENCY AND PRESSURE TESTING. THERE WAS NOTED TO BE A PUMP CONNECTOR ANOMALY. THERE WAS AN INDENTATION DOWN IN THE CUP ALONG WITH RETAINING RING FINGER DAMAGE. IT APPEARS THAT THE SUTURELESS CONNECTOR WAS NOT SEATED PROPERLY INTO THE PUMP OUTLET PORT.

    Additional Manufacturer Narrative · 1

    CATHETER MODEL 8731SC LOT# N263011003 EXPLANTED: (B)(6) 2011. UPDATED EXPLANT DATE OF THE CATHETER. FURTHER ANALYSIS OF THE CATHETER MODEL 8709SC LOT# N137764013 SHOWED NO SIGNIFICANT ANOMALIES. ADDITIONAL ANALYSIS FOUND THAT A PORTION OF THE LUMEN WAS STILL OPEN. THE MISALIGNMENT WOULD, THUS, NOT IMPACT PRODUCT PERFORMANCE.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A LACK OF EFFICACY. A DYE AND ROLLER STUDY WERE DONE AND THEY DIDN'T SEE ANYTHING. THEY THEN DID "A TRIAL AROUND THE CATHETER". THERE WAS NO MAJOR RESPONSE DURING THE TRIAL. THEY DECIDED TO REPLACE THE ENTIRE SYSTEM. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL. SEE MFR REPORT # 3004209178-2010-08552 FOR SUBSEQUENT EVENTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention EXPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 8637-40| CATHETER: MODEL 8709SC, LOT# N156287017| IMPLANTED:| CATHETER: MODEL 8731SC, LOT# N263011003| CATHETER: MODEL 8731SC, LOT# N230290013| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N227837005| IMPLANTED:| LOT# NGV435213H| EXPLANTED:| IMPLANTED:| LOT# N189422| UNKNOWN CONVERSION TYPE: MODEL 8590-9| EXPLANTED:| IMPLANTED: