BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5844049 · Received August 3, 2016

    Report

    Report Number
    3007566237-2016-02819
    Event Type
    Injury
    Date Received
    August 3, 2016
    Date of Event
    July 7, 2016
    Report Date
    March 10, 2017
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0497-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THE MANUFACTURING SITE ID WAS UPDATED.

    Additional Manufacturer Narrative · 1

    INTERROGATION OF THE RETURNED PUMP REVEALED INFUSION OF NORMAL SALINE AT 0.0999 ML/DAY. ANALYSIS OF THE PUMP REVEALED PUMP MOTOR GEAR TRAIN ANOMALIES. THESE INCLUDED CORROSION AND/OR WEAR AND/OR LUBRICATION AND STALL DUE TO SHAFT-BEARING. CONCLUSION CODE NO LONGER APPLIES TO THIS EVENT.

    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. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL VIA A REPRESENTATIVE REGARDING A PATIENT IN (B)(6) WHO WAS RECEIVING BUPIVA CAINE AND MARCAINE VIA AN IMPLANTABLE PUMP. THE CONCENTRATIONS AND DOSAGES WERE REQUESTED BUT UNKNOWN. REPORTEDLY, THE PATIENT HAD MARCAINE FOR APPROXIMATELY ONE YEAR AND THEN BUPIVACAINE THE REST OF THE TIME. IT WAS REPORTED THAT A MOTOR STALL WAS SEEN AT THE "INITIAL" INTERROGATION. THERE WERE A SERIES OF MOTOR STALLS AND RECOVERIES STAR TING ON (B)(6) 2016 AND THEN A HARD STALL ON (B)(6) 2016 FOLLOWED BY A TUBE SET; MOTOR STALL ON (B)(6) 2016 AT 20:19, RECOVERY ON (B)(6) 2016 AT 13:48; MOTOR STALL ON (B)(6) 2016 17:14, RECOVERY ON (B)(6) 2016 14:39; MOTOR STALL ON (B)(6) 2016 17:31, RECOVERY ON (B)(6) 2016 AT 11:30; MOTOR STALL ON (B)(6) 2016 AT 12:58 AND STOPPED PUMP PERIOD MAY EXCEED TUBE SET ON (B)(6) 2016 12:58. THE PATIENT WAS NOT EXPOSED TO A RECENT MAGNETIC RESONANCE IMAGING (MRI) SCAN. THEY DID NOT BELIEVE THERE WERE ANY MAGNETS OR OTHER ELECTROMAGNETIC INTERFERENCES CAUSING THE STALL. THE HEALTH CARE PROVIDER WOULD BE REPLACING THE PUMP. NO PATIENT SYMPTOMS WERE REPORTED. THE SERIAL NUMBER, CAUSE OF THE STALLS, DIAGNOSTICS, ACTIONS AND INTERVENTIONS, RESOLUTION, AND OUTCOME WERE REQUESTED BUT REPORTED AS UNOBTAINABLE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED ON (B)(6) 2016 FROM A HEALTH CARE PROVIDER WHO FURTHER REPORTED THAT THE PATIENT EXPERIENCED SUDDEN WITHDRAWAL WITH REPORT OF THE MOTOR STALLS. THE PUMP HAD NOT RECOVERED SINCE (B)(6). THE PUMP HAD CONTAINED BUPIVACAINE 10 MG/ML AT A DOSE OF 10 MG/DAY AND MORPHINE 2 MG/ML AT A DOSE OF 2 MG/DAY BUT NOW CONTAINED SALINE 1 ML/ML AT 1 ML/DAY. THE RETURN OF THE PUMP STATUS REMAINS UNCLEAR. NO FURTHER INFORMATION COULD BE OBTAINED.

    Description of Event or Problem · 1

    (B)(4): ON 2017-JAN-09 INFORMATION WAS RECEIVED FROM THE PATIENT VIA A HEALTH CARE PROFESSIONAL. ADDITIONAL PATIENT INFORMATION AND IMPLANT DATE OF THE PUMP WERE PROVIDED. THE PATIENT¿S MEDICAL HISTORY INCLUDED COMPLEX BACK PAIN. ACTIONS TAKEN AS A RESULT OF THE EVENT INCLUDED MEDICATION CHANGES, NOTED AS SWITCHING TO ORAL MEDICATIONS, AND DIAGNOSTIC TESTING. AS A RESULT OF THE UNEXPECTED AND REPEAT MOTOR STALLS, A NEW PUMP WAS IMPLANTED ON (B)(6) 2016 ONCE FUNDING WAS ESTABLISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496360 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention