BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2873608 · Received December 14, 2012

    Report

    Report Number
    3004209178-2012-11826
    Event Type
    Injury
    Date Received
    December 14, 2012
    Report Date
    November 14, 2012
    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
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER MODEL: 8731SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: UNK. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND NO ANOMALY. ANALYSIS OF THE CATHETER (B)(4) FOUND ANOMALY WITH THE SUTURELESS CONNECTOR. INDENT IN SEAL AND OCCLUSION RELATED TO COMPLAINT WERE FOUND.

    Description of Event or Problem · 1

    A VOLUME DISCREPANCY WAS REPORTED ON THE DATE OF THIS REPORT; "THE EXPECTED VOLUME WAS 5ML AND THE ACTUAL VOLUME WAS 40ML WHEN THE PUMP WAS INTERROGATED DURING A REFILL." NO LOGS WERE ACQUIRED AND READ AT THE TIME. HEALTHCARE PROVIDER (HCP) PUT BACK ALL 40 ML'S OF DRUG SHE ASPIRATED AND LOWERED THE DOSE TO 50MCG/DAY. FOLLOWING THIS REFILL, HCP HAD PATIENT COME BACK TO THE OFFICE ON (B)(6) 2012 FOR PUMP INTERROGATION. PUMP LOGS WERE READ DATED FROM (B)(6) 2012 AND THERE WERE NO ALARM OR MOTOR STALL EVENT/MESSAGES. UPON INTERROGATION, 39.5 ML OF THE DRUG WAS LISTED AS THE CURRENT PUMP VOLUME WITH PATIENT STILL ON 50 MCG/DAY SIMPLE CONTINUOUS DOSING. PER HCP SINCE IMPLANT THIS SEPTEMBER PATIENT HAD BEEN SEEN SIX TIMES WITH DRUG INCREASES FROM 100 MCG/DAY (STARTING DOSE AT IMPLANT) SIMPLE CONTINUOUS DOSING TO 369 MCG/DAY, "WITH NO EFFECT ON SPASTICITY." PATIENT REPORTED INCREASED SPASTICITY. DRUG DELIVERED VIA THE DEVICE WAS GABLOFEN. IT WAS STATED THAT AS OF NOW NO ACTIONS WERE TAKEN, BUT HCP PLANNED TO PERFORM CAP (CATHETER ACCESS PORT) STUDY EITHER WITH OR WITHOUT FLUOROSCOPY TO DETERMINE CATHETER STATUS/PATENCY. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PUMP AND CATHETER WERE REPLACED ON (B)(6) 2012.

    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