BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2244029 · Received August 24, 2011

    Report

    Report Number
    3004209178-2011-06813
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    January 1, 2011
    Report Date
    August 1, 2011
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER (MODEL 8709SC, SERIAL # (B)(4)) FOUND INDENT IN SEAL AND OCCLUSION RELATED TO COMPLAINT IN THE SUTURELESS CONNECTOR. UNDER MICROSCOPE INSPECTION, A CIRCULAR INDENT COULD BE SEEN IN THE BOTTOM OF THE CUP OF THE SUTURELESS 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 SUTURELESS CONNECTOR. THIS INDICATED THAT THE CONNECTION BETWEEN THE SUTURELESS CONNECTOR AND THE PUMP'S OUTLET PORT MAY POSSIBLY HAVE BEEN OCCLUDED.

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL SUBMITTED TO UPDATE/CORRECT CONCLUSION CODES. ALL PREVIOUSLY REPORTED PATIENT AND DEVICE CODES WILL BE UPDATED/CORRECTED TO THE FOLLOWING FOR THIS EVENT: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER RECEIVED THERAPEUTIC EFFECT. AN UNDISCLOSED CATHETER PROBLEM WAS REPORTED. ALSO, THERE WAS A PUMP ALARM, TELEMETRY HAD NOT BEEN PERFORMED AT THE TIME THE EVENT WAS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS SEEN BY THE HEALTH CARE PROVIDER (HCP) BECAUSE THE LOW RESERVOIR ALARM WAS HEARD. IT WAS NOTED THAT THERE WAS MORE MEDICINE IN THE PUMP THAN ON THE PRINTER LOGS. THE PUMP WAS BEING USED TO DELIVER DILAUDID. THE HCP WITHDREW ALL THE MEDICATION FROM THE PUMP AND FILLED THE PUMP WITH SALINE. IT WAS REPORTED THAT A CATHETER STUDY WAS ATTEMPTED IN 2011 AND THE CATHETER COULD NOT BE ASPIRATED. THE PATIENT HAD PAIN AND LESS THAN 50 PERCENT THERAPY RELIEF. THE CATHETER WAS REPLACED ON (B)(6) 2013. THE PUMP WAS PROGRAMMED AT 0.1 MG/DAY OF 2 MG/ML DILAUDID. THE PATIENT EXPERIENCED ITCHING 'ALL OVER' AND THE HCP DECREASED THE PUMP TO MINIMUM RATE. THE PATIENT WAS DISCHARGED ON (B)(6) 2013 AND WAS INSTRUCTED TO FOLLOW UP WITH HER DOCTOR. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 REPORTED THAT THE PATIENT EXPERIENCED HEADACHE THAT WORSENED WHEN SHE WAS UPRIGHT AND IMPROVED WHEN SHE LAY DOWN. THE PATIENT WAS SCHEDULED FOR ANOTHER CATHETER DYE STUDY. THE PUMP WAS IN MINIMUM RATE MODE AS OF (B)(6) 2013.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR Required Intervention CATHETER: MODEL 8709SC, LOT# N274709014| IMPLANTED:| EXPLANTED: