BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2833754 · Received November 15, 2012

    Report

    Report Number
    3004209178-2012-10305
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    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
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE PUMP FOUND NO ANOMALIES. THE PUMP PASSED ALL NON-DESTRUCTIVE TESTING AND THERE WERE NO ANOMALIES IN THE NOTED IN THE PUMP LOGS.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING REFILL ON (B)(6) 2012 THAT THE RESERVOIR STILL CONTAINED 40ML OF CLEAR LIQUID, INDICATING THAT THE PUMP MAY NOT HAVE DELIVERED ANY MEDICINE AT ALL. THE PATIENT HAD SOME DIFFICULTY INCLUDING, "MORE SPASTIC THAN NORMAL" AND WAS GIVEN ORAL BACLOFEN PILLS TO REDUCE "ABSTINENCE AND SPASTICITY". IT WAS INDICATED THAT THE REFILL WAS DONE AND THEY PROGRAMMED A SINGLE BOLUS DOSAGE OF 50MCG ON THREE SEPARATE DAYS. IT WAS BELIEVED THAT THERE WAS SOME EFFECT ON THE FIRST 2 BOLUSES; HOWEVER, THE 3RD BOLUS THERE WAS NO CLINICAL EFFECT. WHEN EMPTYING THE PUMP AGAIN, IT WAS DISCOVERED THAT IT ONLY HAD DELIVERED APPROXIMATELY HALF THE CALCULATED AMOUNT. DURING ANOTHER REFILL 36ML WAS EXTRACTED FROM THE RESERVOIR, BUT ACCORDING TO THE CALCULATED AMOUNT, THERE SHOULD HAVE BEEN 31.5ML, WHICH MEANT THAT THE PUMP HAD NOT DELIVERED 4.5ML DURING THE LAST 6 DAYS. THE PUMP WAS REPLACED AND THE SAME CATHETER WAS MAINTAINED SINCE IT HAD APPEARED TO BE FUNCTIONING WELL. THERE WAS NO OTHER TROUBLE-SHOOTING PERFORMED. IT WAS INDICATED THAT THE PATIENT WAS NOW VERY WELL TREATED AND IS RECEIVING HALF THE DOSAGE OF THE FIRST PUMP. THE DRUG DELIVERED VIA PUMP WAS LIORESAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00032 YR Required Intervention