BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4212158 · Received October 29, 2014

    Report

    Report Number
    3007566237-2014-03159
    Event Type
    Injury
    Date Received
    October 29, 2014
    Report Date
    October 3, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND MOTOR GEAR TRAIN ANOMALIES. THERE WAS CORROSION AND/OR WEAR AND/OR LUBRICATION AND A STALL DUE TO SHA FT-BEARING.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A FAILED PUMP AND HAD SOME QUESTIONS ABOUT THE COST OF PUMP REPLACEMENT. AT THE TIME OF THIS REPORT, THE PUMP HAD BEEN ALARMING EVERY COUPLE OF HOURS SINCE THE LAST WEEK OF (B)(6). THE ALARM WAS DUE TO A PUMP MALFUNCTION AND THE PUMP WAS NOT DELIVERING ANY MEDICATION. AS OF (B)(6) 2014, THE PATIENT WAS STILL HAVING CONCERNS WITH HIS DEVICE OR THERAPY BUT WAS WORKING WITH HIS DOCTOR. HIS NEXT APPOINTMENT DATE HAD YET TO BE DETERMINED. THE DEVICE SYSTEM WAS USED TO DELIVER FENTANYL.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED, PER PUMP LOGS, THAT A MOTOR STALL OCCURRED ON (B)(6) 2014 AT 07:25 WITH A TUBE SET MESSAGE 48 HOURS LATER. AS OF (B)(6) 2014, THE STALL HAD NOT RECOVERED. THE CAUSE OF THE STALL WAS NOT DETERMINED. WHEN THE PUMP FIRST STARTED TO ALARM, THE PATIENT REPORTED WITHDRAWAL/UNDERDOSE SYMPTOMS. THE PATIENT ALSO EXPERIENCED FLU-LIKE SYMPTOMS, RETURN OF PAIN, AND SWEATING. PER PUMP LOGS, A LOW RESERVOIR ALARM OCCURRED ON (B)(6) 2014 AT 21:43 AND AN EMPTY RESERVOIR ALARM OCCURRED THE SAME DATE AT 21:51. THE PUMP WAS REPLACED ON (B)(6) 2014. AS OF (B)(6) 2014, THE PATIENT HAD BEEN DOING VERY WELL SINCE THE PUMP REPLACEMENT. THE DEVICE SYSTEM WAS USED TO DELIVER FENTANYL 400MCG/ML AT 200.02MCG/DAY AND BUPIVACAINE 5MG/ML AT 2.5003MG/DAY. FOLLOWING THE PUMP REPLACEMENT, THE PUMP WAS FILLED WITH FENTANYL AT 25.023MCG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692371 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention