BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2893753 · Received January 2, 2013

    Report

    Report Number
    3004209178-2013-00068
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 4, 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
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED THE PUMP HAD PASSED ALL INFUSION, NON-DESTRUCTIVE, AND VOLUME TESTING. DISPENSE TESTING AND AN ADDITIONAL 28 DAY VOLUME TESTING ALL PASSED SHOWING THAT THE PUMP WAS DISPENSING ACCURATELY. NO ANOMALIES WHERE NOTED IN THE LOGS. HOWEVER, THIS PUMP FAILED ALARM TESTING WITH AN AUDIBLE TONE ON 67.3 DB. ANALYSIS WAS PERFORMED AND A CRACKED RESONATOR WITH NO ASSOCIATED TOP SHIELD DAMAGE WAS NOTED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN UNEXPECTEDLY HIGH "RESIDUE VOLUME" WAS REPORTED. THE PATIENT'S PHYSICIAN BELIEVED THAT THE ACTUAL RESIDUAL VOLUME WAS GREATER THAN 15% ABOVE THE EXPECTED AMOUNT. A DYE STUDY WAS DONE WITHOUT ANY INDICATION OF DAMAGE TO THE CATHETER. THE PUMP WAS REPLACED DUE TO THE "BREAKAGE IN A LEAD/EXTENSION/ACCESSORY." THE PATIENT EXPERIENCED UNCONTROLLED MUSCLE CONTRACTIONS, TREMOR, AND AN INCREASE IN SYMPTOMS. THE MEDICATION USED WITHIN THE SYSTEM WAS BACLOFEN. NO PATIENT INJURY OR PROBLEMS POST PUMP REPLACEMENT WERE REPORTED, AND THE PATIENT RECOVERED WITHOUT SEQUELAE. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention