BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5113809 · Received September 30, 2015

    Report

    Report Number
    3004209178-2015-19010
    Event Type
    Injury
    Date Received
    September 30, 2015
    Report Date
    September 18, 2015
    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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING MEDICATION VIA AN IMPLANTABLE PUMP. THE INDICATION FOR USE WAS NON-MALIGNANT PAIN. ON (B)(6) 2015 IT WAS REPORTED THAT THE PUMP "FAILED". THE PUMP WAS REPLACED. THE CAUSE OF THE EVENT, TROUBLESHOOTING PERFORMED, PATIENT SYMPTOMS RELATED TO THE EVENT, AND DRUG IN THE PUMP AT THE TIME OF THE EVENT WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT RECEIVING FENTANYL (2000 MCG/ML AT 1031 MCG/DAY) VIA AN IMPLANTABLE INFUSION PUMP. THE PATIENT'S PERTINENT MEDICAL HISTORY INCLUDED CHRONIC PAIN, HYPERTENSION, PERIPHERAL VASCULAR DISEASE, PNEUMONIA, DEPRESSION, UTERINE CANCER, HEART DISEASE, HEART ATTACK, COPD, PACEMAKER, TONSILLECTOMY, APPENDECTOMY, TUBAL LIGATION, GASTRIC SURGERY, ENDOMETRIAL ABLATION, LAPAROTOMY, CHOLECYSTECTOMY, THROAT SURGERY, BACK SURGERY, AND LEG SURGERY. THE OTHER MEDICATIONS THE PATIENT WAS TAKING AT THE TIME OF THE EVENT INCLUDED HYDROMORPHONE, CYMBALTA, LYRICA, PROVIGIL, CLONAZEPAM, TIZANIDINE, AND FIORICET. THE LOGS SHOWED THE PATIENT'S PUMP HAD MULTIPLE MOTOR STALLS AND RECOVERIES. A MOTOR STALL RECOVERY OCCURRED ON (B)(6) 2015 AT 01:53. A MOTOR STALL OCCURRED ON (B)(6) 2015 AT 02:11 WITH A RECOVERY ON (B)(6) 2015 AT 02:28. A MOTOR STALL OCCURRED ON (B)(6) 2015 AT 03:40 WITH A RECOVERY ON (B)(6) 2015 AT 04:17. A MOTOR STALL OCCURRED ON (B)(6) 2015 AT 17:03 WITH A RECOVERY ON (B)(6) 2015 AT 17:20. A MOTOR STALL OCCURRED ON (B)(6) 2015 AT 00:08 WITH A RECOVERY ON (B)(6) 2015 AT 00:47. A MOTOR STALL OCCURRED ON (B)(6) 2015 AT 01:39 WITH A RECOVERY ON (B)(6) 2015 AT 02:16. A MOTOR STALL OCCURRED ON (B)(6) 2015 AT 04:38 WITH A RECOVERY ON (B)(6) 2015 AT 04:57. A MOTOR STALL OCCURRED ON (B)(6) 2015 AT 06:45 WITH A RECOVERY ON (B)(6) 2015 AT 08:02. A MOTOR STALL OCCURRED ON (B)(6) 2015 AT 13:52 WITH A RECOVERY ON (B)(6) 2015 AT 14:09. A MOTOR STALL OCCURRED ON (B)(6) 2015 AT 14:27 WITH A RECOVERY ON (B)(6) 2015 AT 15:04. A MOTOR STALL OCCURRED ON (B)(6) 2015 AT 15:22 WITH A RECOVERY ON (B)(6) 2015 AT 19:15. A MOTOR STALL OCCURRED ON (B)(6) 2015 AT 20:09 WITH A RECOVERY ON (B)(6) 2015 AT 20:46. A MOTOR STALL OCCURRED ON (B)(6) 2015 AT 21:02 WITH A RECOVERY ON (B)(6) 2015 AT 21:21. A MOTOR STALL OCCURRED ON (B)(6) 2015 AT 22:33 WITH A RECOVERY ON (B)(6) 2015 AT 22:50. A MOTOR STALL OCCURRED ON (B)(6) 2015 AT 04:28 WITH A RECOVERY ON (B)(6) 2015 AT 05:59. A MOTOR STALL OCCURRED ON (B)(6) 2015 AT 08:21. THE PATIENT WAS SEEN IN THE CLINIC ON (B)(6) 2015. THE SYMPTOMS EXPERIENCED RELATED TO THE MOTOR STALL INCLUDED DIAPHORESIS, TREMORS, ANXIETY, AND ELEVATION IN PAIN LEVEL. THE HCP DECREASED THE PUMP CONTINUOUS RATE AND PATIENT ACTIVATED (PA) DOSE AND STARTED THE PATIENT ON FENTANYL PATCHES TO HELP WITH THE SYMPTOMS OF WITHDRAWAL/ELEVATION IN PAIN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645593 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention