BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2901080 · Received January 8, 2013

    Report

    Report Number
    3004209178-2013-00283
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    September 4, 2012
    Report Date
    March 15, 2017
    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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), EXPLANTED: 2012-(B)(6), PRODUCT TYPE CATHETER.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    (B)(4).

    Description of Event or Problem · 1

    A CATHETER BREAK WAS REPORTED. THE DISTAL END OF CATHETER BROKE AND PATIENT HAD LOSS OF THERAPY, UNDERDOSE SYMPTOMS. IT WAS NOTED THAT "PART" OF THE DISTAL END OF CATHETER REMAINS IN THE PATIENT. STATUS AT THE TIME OF THIS REPORT WAS LISTED AS ALIVE, NO INJURY, NO ADVERSE EVENT. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE DEVICE HAD BEEN EXPLANTED. IT WAS STATED THAT THERE WAS PATIENT INJURY AS A RESULT OF THE EVENT. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES A VAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A CONSUMER INDICATED THE PATIENT GRADUALLY EXPERIENCED WONDERFUL PAIN RELIEF UNTIL ON OR ABOUT THE (B)(6) 2012, WHEN HE REPORTED TO THE EMERGENCY ROOM EXPERIENCING ACUTE PAIN. THE DOCTOR FOUND THE CATHETER HAD MALFUNCTIONED AND WAS LEAKING MORPHINE INTO HIS BODY. DURING THE REMOVAL THE CATHETER WAS FOUND TO BE BROKEN IN SEVERAL PLACES, INCLUDING WITHIN THE SPINAL CANAL (IT SPACE). THE PORTION THAT WAS EXPLANTED WAS DESTROYED BY THE DEFENDANT HOSPITAL. IT WAS NOTED THE CATHETER FAILURE HAD AGGRAVATED HIS PREVIOUS CONDITION OF FAILED SURGICAL BACK.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS PREVIOUSLY REPORTED UNDER MANUFACTURER REPORT # 3007566237-2014-02783. ADDITIONAL REVIEW INDICATES THIS INFORMATION PERTAINS TO THIS MANUFACTURER REPORT. [IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT HAD A PAIN PUMP AND SPINAL CATHETER IMPLANTED TO PROVIDE RELIEF FROM INTRACTABLE SPINAL PAIN. ON OR ABOUT (B)(6) 2012 THE CATHETER MALFUNCTIONED "ON INFORMATION AND BELIEF" FROM A MANUFACTURING DEFECT. THE CATHETER DID NOT TRANSMIT PAIN RELIEVING MEDICATION FROM THE PUMP TO THE PATIENT'S INTRATHECAL SPACE. THE CATHETER HAD BROKEN AND FAILED TO DELIVER ANALGESICS TO THE PATIENT'S INTRATHECAL AREA WHICH NECESSITATED SURGICAL REMOVAL, AND CAUSED THE PATIENT TO SUFFER PERMANENT AND PERMANENTLY DISABLING INJURIES. THE CATHETER WAS EXPLANTED ON (B)(6) 2012. THE PATIENT CONTINUED TO EXPERIENCE GREAT PAIN AND MENTAL ANGUISH AS WELL AS LOSS OF NORMAL LIFE. THE MEDICATION DELIVERED BY THE DEVICE SYSTEM WAS NOT PROVIDED.] IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9649 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention| S