BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3546975 · Received January 2, 2014

    Report

    Report Number
    3004209178-2014-00030
    Event Type
    Injury
    Date Received
    January 2, 2014
    Report Date
    December 12, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 8590-1, LOT# N242388, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8598A , SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE PUMP FOUND NO ANOMALIES. THE PUMP PASSED ALL NON-DESTRUCTIVE TESTING. THERE WERE MOTOR STALLS AND RECOVERIES IN THE LOGS; HOWEVER, THEY HAD OCCURRED AFTER EXPLANT. AFTER PERFORMING DESTRUCTIVE ANALYSIS, NOTHING SIGNIFICANT WAS FOUND THAT MIGHT CAUSE THE MOTOR STALLS. FINAL ANALYSIS OF THE CATHETER FOUND A NON-SIGNIFICANT INDENT IN THE SEAL OF THE SUTURELESS CONNECTOR THAT DID NOT AFFECT INFUSION. ALSO, THERE WAS SOME NON-SIGNIFICANT TWISTING SEEN ON A SEGMENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ACCORDING TO HEALTH CARE PROVIDER (HCP) NOTES, THE PATIENT HAD MULTIPLE INCREASES IN THEIR DOSE BUT NO INCREASE IN RELIEF. THERE WAS NO DOCUMENTATION OF ANY DIAGNOSTIC STUDIES. SYMPTOMS ASSOCIATED WITH THE EVENT INCLUDED PAIN. ACTIONS REQUIRED AS A RESULT OF THE EVENT INCLUDED DEVICE SYSTEM EXPLANT. THE PATIENT¿S STATUS AT THE TIME OF REPORT WAS LISTED AS ¿ALIVE ¿ NO INJURY¿. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD AN INCREASE IN PAIN AND A DECREASE OF INTRATHECAL (IT) PUMP. IT WAS NOTED THAT IT WAS ¿UNDESIRED PER PATIENT¿. IT WAS REPORTED THAT THERE WAS AN EXPLANT (B)(6) 2013. IT WAS LATER REPORTED THAT THE PUMP WAS NOT AN ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention