BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2580469 · Received May 18, 2012

    Report

    Report Number
    3004209178-2012-03492
    Event Type
    Injury
    Date Received
    May 18, 2012
    Date of Event
    April 23, 2012
    Report Date
    April 23, 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
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    CATHETER MODEL 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: UNK; ACCESSORY 8590-1, LOT # N151979, IMPLANTED: (B)(6) 2008, EXPLANTED: UNK; ACCESSORY MODEL 8578, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: UNK.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL ANAYLSIS OF THE PUMP FOUND PUMP MOTOR GEAR TRAIN ANOMALY: CORROSION.

    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

    INITIALLY, IT WAS REPORTED THE PATIENT EXPERIENCED A CHANGE IN THERAPY EFFECT: INCREASED PAIN IN TRUNK AND LEGS. A PUMP ALARM WAS HEARD; TELEMETRY CONFIRMED A CRITICAL ALARM WAS OCCURRING DUE TO MOTOR STALL. THE STALL WAS CONSTANT WITH NO RECOVERY RECORDED. LOGS SHOWED THE PUMP STALLED AT 07:10 AM ON (B)(6) 2012. THE ERI WAS 34 MONTHS. THE HCP WAS UNAWARE OF ANY ENVIRONMENTAL FACTOR THAT COULD HAVE CAUSED THE STALL. THE STALL OCCURRED WHILE THE PATIENT WAS AT HOME. THE PUMP WAS PROGRAMMED TO MINIMUM RATE MODE IN CASE THE STALL RECOVERED. THE PATIENT WAS BEING MANAGED WITH MEDICATIONS VIA OTHER ROUTES (ORAL/INTRAVENOUS). THE PATIENT DID NOT EXPERIENCE WITHDRAWAL AS THE PUMP ALARM WAS ADDRESSED RIGHT AWAY. THE PUMP CONTAINED: MORPHINE, CLONIDINE, BUPIVACAINE (MARCAINE), AND BACLOFEN. AS OF (B)(6) 2012, THE PLAN WAS TO REPLACE THE PUMP. IT WAS LATER REPORTED ON (B)(6) 2012 THAT DURING THE PATIENT'S PREVIOUS CATHETER REPLACEMENT (SEE MFR REPORT 3004209178-2012-02247); THE HCP DECIDED THE PUMP WAS NOT THAT OLD SO IT WAS NOT REPLACED. NOW THE PUMP "HAS REACHED EOS" AND THE PATIENT WAS UPSET HE NEEDED ANOTHER DEVICE RELATED SURGERY. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION [THE REPORTER STATED THAT THE PUMP WAS NOT DISPENSING MEDICATION ACCURATELY AND ¿WAS OFF BY 20 ¿ 30%.¿] WAS PREVIOUSLY REPORTED IN MANUFACTURER REPORT #S 3004209178-2012-02247 AND 3004209178-2012-03492. FURTHER REVIEW DETERMINED THE INFORMATION IS ONLY RELATED TO MANUFACTURER REPORT # 3004209178-2012-02247; ANY ADDITIONAL INFORMATION RECEIVED WILL BE REPORTED IN MANUFACTURER REPORT #3004209178-2012-02247.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED BY A COMPANY REPRESENTATIVE REPORTING THE DOSES AT THE TIME OF THE EVENT WERE BACLOFEN 63 MCG/DAY, MORPHINE 14 MG/DAY, BUPIVACAINE 6.3 MG/DAY, AND CLONIDINE 255 MCG/DAY. INDICATIONS FOR USE WERE LUMBAR RADICULOPATHY AND NON-MALIGNANT PAIN.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW REVEALED THAT THE HEALTHCARE PROFESSIONAL HAD ALSO REPORTED THAT THE PATIENT THOUGHT THAT THE ALARM WAS HIS DAUGHTER'S ALARM AND HE DIDN'T RECOGNIZE THAT IT WAS COMING FROM "HIMSELF." IT WAS STATED THAT THE PUMP HAD ALARMED 8 TIMES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PUMP DIED PREMATURELY. THE REPORTER STATED THAT THE PUMP WAS NOT DISPENSING MEDICATION ACCURATELY AND "WAS OFF BY 20 - 30%". THE PATIENT STATED THAT THE HEALTHCARE PROVIDER (HCP) THOUGHT THE CATHETER WAS THE ISSUE AND THEREFORE IT WAS REPLACED (REFER TO MANUFACTURER REPORT #3004209178-2012-02247), BUT LATER A MOTOR STALL OCCURRED AND THE PUMP HAD TO BE REPLACED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS CONFIRMED THAT THE MOTOR STALL OCCURRED ON (B)(6) 2012 AND THE RELATED ALARM WAS SILENCED ON THE SAME DAY. TUBE SET EXCEEDED 48 HRS MESSAGE APPEARED ON (B)(6) 2012 AND THE RELATED ALARM WAS SILENCED AGAIN (B)(6) 2012. MOTOR STALL RECOVERY OCCURRED AFTER THE PUMP WAS EXPLANTED. IT WAS ALSO NOTED THAT PATIENT HAD REQUESTED ALTERNATE PHYSICIANS FOR SECOND OPINION ON STEPS TO PROCEED. PATIENT WAS WITHOUT INJURY AND FOLLOWING PUMP REPLACEMENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention