BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3833646 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-09655
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    May 5, 2014
    Report Date
    September 6, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-3043-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP (SN (B)(4)) FOUND A MANUFACTURING ISSUE, A MISCELLANEOUS WIRE WELD ANOMALY. THE INSPECTION OF THE HYBRID FOUND A MISSING RESISTANCE WELD FOR THE B+ WIRE POST. (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

    CONCLUSION CODE WAS UPDATED. RECENT FDA CODING CHANGES OFFER LIMITED OPTIONS FOR MEDICAL DEVICE EVALUATION CONCLUSION CODING. MEDTRONIC SELECTED CONCLUSION CODE BECAUSE THIS IS THE CLOSEST CODE AVAILABLE WITH RESPECT TO THIS EVENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED A CRITICAL ALARM WAS HEARD AND CONFIRMED BY TELEMETRY. PUMP LOGS SHOWED A "RESET OCCURRED - LOW BATTERY" AND SAFE STATE OCCURRED ON (B)(6) 2014. THE PATIENT WENT TO THE ER ON MONDAY NIGHT AND WAS EXPERIENCING A RETURN OF SYMPTOMS INCLUDING PAIN AND RESTLESS LEG SYNDROME. ON (B)(6) 2014, THE PUMP WAS PROGRAMMED TO THE MINIMUM RATE MODE AND WAS USED FOR THERAPY AT THIS RATE. IT WAS STATED THE PATIENT DID NOT HEAR ANY BEEPING OR ALARMS. THE PUMP WAS GOING TO BE REPLACED. THE PUMP WAS USED TO INFUSE MORPHINE. (B)(6) 2014 (LFC/HCP); IT WAS FURTHER REPORTED THE PATIENT WAS HAVING "WITHDRAWALS", AN INCREASE IN LOWER BACK PAIN, LEG SPASMS AND MENTAL CONFUSION. IT WAS NOTED THE PUMP "FAILED" AND WENT INTO SAFE MODE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PUMP WAS BEING REPLACED THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER. IT WAS REPORTED THAT THE PATIENT WENT OUT OF THEIR MIND AND WALKED STRAIGHT INTO A POND. THE CHANGE IN THERAPY/SYMPTOMS WAS CONSIDERED SUDDEN. THE SITUATION WAS RESOLVED. THE COGNITIVE ISSUE OCCURRED IN 2014 WHEN THE PUMP STOPPED WORKING FOR TWO WEEKS. THE PUMP WAS USED TO INFUSE DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310322 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention