BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4093991 · Received September 16, 2014

    Report

    Report Number
    3004209178-2014-17144
    Event Type
    Injury
    Date Received
    September 16, 2014
    Report Date
    August 23, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP, MODEL# 8637-20, SN (B)(4), FOUND NO ANOMALY. ANALYSIS OF THE CATHETER, MODEL# 8709SC, SN (B)(4), FOUND NO SIGNIFICANT ANOMALIES. A BEND WAS FOUND CLOSE TO THE SUTURELESS CONNECTOR. NO KINKING OCCURRED WHEN THE CATHETER WAS BENT TO A NARROWER RADIUS. THE BEND DID NOT AFFECT INFUSION. CONCLUSION: NO LONGER APPLIES TO THE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, 4 DAYS AGO, THE PATIENT HAD A RETURN IN PAIN THAT CAME ON SUDDENLY. IT WAS ALSO NOTED THAT THE PATIENT FELL AT HOME 4 DAYS AGO AS WELL. THE PATIENT STATED THAT THEIR PUMP WAS NOT WORKING, AND THAT THE MANAGING PHYSICIAN HAD NOT YET CHECKED THE PUMP. ADDITIONALLY, THE PATIENT HAD BEEN IN THE HOSPITAL FOR THREE DAYS, AND THE PUMP HAD NOT BEEN CHECKED. THE REPORTER STATED THAT THE HOSPITALIZATION WAS NOT RELATED TO THE PUMP. IT WAS ALSO NOTED THAT NO ONE COULD FIGURE OUT WHY THE PUMP WAS NOT WORKING. THE REPORTER WAS REDIRECTED TO THE PATIENT¿S HCP (HEALTHCARE PROVIDER). THE PUMP WAS BEING USED TO DELIVER DILAUDID (HYDROMORPHONE). NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCED LOSS OF THERAPEUTIC EFFICACY AT 18 MONTHS POST IMPLANT. THE DRUG WAS REPLACED WITH PRESERVATIVE FREE NORMAL SALINE AT THAT TIME. THE PATIENT AND THE PHYSICIAN OPTED FOR PUMP AND CATHETER REMOVAL ON THE DAY OF THE REPORT. DURING THE PROCEDURE, THE CATHETER WAS FOUND TO BE KINKED AT THE PUMP CONNECTOR. THE KINK WAS STRAIGHTENED AND CEREBROSPINAL FLUID (CSF) BACKFLOW WAS SEEN. BODY TISSUE WAS ALSO NOTED WITH IN THE CATHETER CONNECTOR. THE PUMP WAS BOLUSED ON THE BACK TABLE AND FLUID DROPLETS WERE EXPELLED FROM THE CATHETER CONNECTION PORT. THE PATIENT'S STATUS AT THE TIME OF THE EVENT WAS STATED TO BE ALIVE WITH NO INJURY. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570863 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Required Intervention