BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2190737 · Received July 26, 2011

    Report

    Report Number
    3004209178-2011-05789
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    May 11, 2011
    Report Date
    July 6, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL ANALYSIS OF THE DEVICE REVEALED NO ANOMALY, NORMAL DEVICE FUNCTIONING. ONLY THE SC ASSEMBLY WAS RETURNED FOR ANALYSIS THAT REVEALED A PUMP-CONNECTOR ANOMALY. A DRIED DRUG OCCLUSION WAS SEEN IN THE SC CONNECTOR. A CIRCULAR INDENT WAS SEEN IN THE BOTTOM OF THE CUP OF THE SC CONNECTOR. A SIGNIFICANT MAJORITY OF THE INDENT WAS LOCATED IN THE SILICONE MATERIAL OF THE CUP OF THE SC CONNECTOR, INDICATING THE CONNECTION BETWEEN THE SC CONNECTOR AND THE PUMP'S OUTLET PORT MAY POSSIBLY HAVE BEEN OCCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD NO PAIN RELIEF SINCE IMPLANT. ON ATTEMPTING A REFILL (FIRST REFILL FOLLOWING IMPLANT) ON (B)(6) 2011, THE ENTIRE DRUG WAS ASPIRATED. A DYE STUDY DONE ON (B)(6) 2011, THAT SHOWED THE CATHETER PATENT, NO KINKS AND CEREBROSPINAL FLUID (CSF) FREE FLOWING. A ROTOR STUDY WAS PERFORMED AS PRIMING BOLUS 0.01ML OVER 1 MIN, AND ROTOR DID NOT TURN AND DID NOT WORK AFTER WAITING FOR FURTHER TWO MORE MINUTES. THERE WERE NO ALARMS AND NO MOTOR STALLS NOTED IN THE LOGS. PUMP AND SUTURELESS CONNECTOR (SC) WERE EXPLANTED. THE PUMP WAS USED TO DELIVER COMPOUNDED MORPHINE 2MG/ML AT 0.4MG/DAY. FOLLOWING REPLACEMENT, THE PT HAD NOT NOTED ANY PAIN RELIEF, BUT WAS SCHEDULED FOR A F/U ON (B)(6) 2011 POST-OPERATIVELY FOR DOSE INCREASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention ACCESSORY: MODEL 8590-1, LOT # N276995| EXPLANTED:| EXPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT # N283451013| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 8835, LOT # NPG023302N| IMPLANTED: