BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3811416 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-08987
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 24, 2014
    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
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). AS PREVIOUSLY REPORTED: ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP (S/N: (B)(4)) FOUND THE MOTOR STALL WAS DUE TO CORROSION, WEAR, AND/OR LUBRICATION, AND THE GEAR PINION. THERE WAS CORROSION AND MOISTURE ON THE TOP SIDE OF GEAR WHEEL 3. THERE WAS RESIDUE ON THE PINION OF GEAR 2 AND THE TEETH OF GEAR 3.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

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

    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 A MOTOR STALL OCCURRED AND DID NOT RECOVER. FURTHER, A STALL OCCURRED IN MID-(B)(6) AND RECOVERED A FEW HOURS LATER. THE PUMP STALLED MANY TIMES OVER THE NEXT FEW WEEKS AND RESTARTED BUT THEN STOPPED TEN DAYS AFTER THE INITIAL EVENT. THE PATIENT WAS PREVIOUSLY GETTING GOOD THERAPY SINCE IMPLANT. HOWEVER, DID REPORT UNDERDOSE SYMPTOMS INCLUDING ITCHINESS AND THE RETURN OF SPASTICITY THROUGHOUT THE BODY IN ASSOCIATION WITH THIS EVENT. DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS NOT PERFORMED. REPORTEDLY, THE ISSUE WAS RESOLVED BUT THE CAUSE WAS NOT DETERMINED. THE DEVICE STATUS WAS REPORTED AS IMPLANTED-OUT-OF-SERVICE AND THE REPLACEMENT OF THE PUMP WAS PLANNED FOR (B)(6) 2014. THERE WAS NO ALLEGED CATHETER ISSUE. THE PATIENT HAD BEEN ON FLEX DOSING AND WAS NOW ON ORAL BACLOFEN AWAITING THE PUMP REPLACEMENT. THE PUMP WAS EXPECTED TO BE RETURNED UPON ITS EXPLANT. THIS DEVICE SYSTEM DELIVERED COMPOUNDED BACLOFEN. THE CONCENTRATION WAS 2000 MCG/ML AND THE DOSE WAS 205 MCG/DAY BUT THE PUMP WAS PREVIOUSLY FILLED WITH LIORESAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS NOW REPORTED THAT THE DATE OF THE EVENT WAS (B)(6) 2014. THE DATE OF IMPLANT WAS NOW REPORTED TO HAVE OCCURRED APPROXIMATELY ON (B)(6) 2010 AND THIS WAS PREVIOUSLY REPORTED AS APPROXIMATELY (B)(6) 2009. REPORTEDLY, THE PUMP HAD CRITICALLY ALARMED AND INTERROGATION CONFIRMED A STALL THAT HAD NOT RECOVERED. IT WAS ALSO NOW REPORTED THAT THE PUMP DELIVERED LIORESAL. IT WAS ALSO REPORTED THAT IF THE ISSUE WAS RESOLVED OR THE CAUSE DETERMINED WAS REPORTED AS "UNKNOWN, OR N/A." THE PATIENT EXPERIENCED LESS THAN 50% THERAPY RELIEF. AT THE TIME OF THE EVENT THE PATIENT'S STATUS WAS REPORTED AS ALIVE-NO INJURY.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PUMP WAS REVISED AND THE PUMP WAS BEING RETURNED. THE PATIENT WAS DOING WELL POST THE PUMP REPLACEMENT AND WAS RECEIVING GOOD THERAPY. IT WAS FURTHER CLARIFIED THAT THE REVISION TOOK PLACE ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290010 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention