BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3233721 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11964
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 26, 2013
    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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO ANOMALY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    .ADDITIONAL INFORMATION LATER REPORTED THE PATIENT BELIEVED HE WASN¿T GETTING ACCURATE PAIN RELIEF. PER THE REPORTER HE SAW NO ERRORS IN THE PUMP LOGS AND BELIEVED THE PATIENT WAS DOING JUST FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED A CRITICAL ALARM OCCURRED. THE PATIENT THOUGHT HIS PUMP WAS MALFUNCTIONING AND ANOMALIES IN THE PUMP LOGS WERE NOTED. THE PATIENT COMPLAINED OF INTERRUPTED THERAPY, LESS THAN 50% OF THERAPY RELIEF. THE PUMP WAS EXPLANTED. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE, NO INJURY, NO ADVERSE EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THE CAUSE OF THE EVENT WAS DUE TO PUMP MOTOR STALL. THE PATIENT HAD SUDDEN WITHDRAWAL SYMPTOMS DUE TO THE PUMP STALLING. THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THE STALL OCCURRED ON (B)(6) 2013 AND THAT IT NEVER RECOVERED. THE HCP REPLACED THE PUMP ON (B)(6) 2013 AS THE HCP INDICATED IT WAS A NON-FUNCTIONING PUMP. THE HCP REPORTED THAT BEFORE ANY OF THIS THE PATIENT WAS DOING VERY WELL. THE PUMP WAS BEING USED TO MANAGE PAIN WITH RESTLESS LEG SYNDROME. HE DID VERY WELL, BUT WHEN THE MOTOR STALL OCCURRED, THE PATIENT HAD CLASSIC WITHDRAWAL SYMPTOMS. THEY HAD TO MANAGE HIM WITH ORAL MORPHINE UNTIL THEY COULD DO THE REVISION. THE HCP DID NOT HAVE ANY ADDITIONAL LOGS. THE CURRENT PUMP THAT WAS PLACED IN (B)(6), "WORKS LIKE A CHARM." THE PATIENT RECEIVED A 10 % INCREASE TODAY AND IS AT 0.18577 MG/DAY AT 10 MG/ML. THE PATIENT WAS DEVELOPING A SLIGHT TOLERANCE EVEN AT SUCH A LOW DOSE. BUT THERE ARE NO CURRENT DEVICE ISSUES. THE SURGERY IN (B)(6) TOOK CARE OF IT. THE PHYSICIAN ALSO STATED THAT THEY WILL BE GIVING THE PATIENT A PTM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333610 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention