BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3080305 · Received April 26, 2013

    Report

    Report Number
    3004209178-2013-06957
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    March 23, 2013
    Report Date
    March 29, 2013
    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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, LOT# N171026034, IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER. (B)(4). 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 FOUND THERE WERE MULTIPLE MOTOR STALLS AND RECOVERIES OBSERVED IN THE LOGS. DURING DESTRUCTIVE ANALYSIS THE TECHNICIAN FOUND SIGNIFICANT RESIDUE AND SHAFT WEAR ON THE UPPER SHAFT OF GEAR 2. THEY ALSO FOUND SOME RESIDUE ON THE JEWEL WHERE THE UPPER SHAFT OF GEAR 2 INSERTED INTO THE TOP BRIDGE ASSEMBLY. PUMP MOTOR GEAR TRAIN CORROSION AND-OR WEAR AND-OR LUBRICATION, AND STALL DUE TO SHAFT-BEARING WERE ALSO NOTED.

    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 THIS PUMP WAS REFILLED THE WEEK BEFORE THE DATE OF THIS REPORT. AT THAT TIME THE PUMP WAS 'FINE' AND NO ALARM WAS PRESENT. HOWEVER SINCE THEN THE PUMP HAD ALARMED AND TELEMETRY CONFIRMED A MOTOR STALL WITH NO STALL RECOVERY. A REVIEW OF THE PUMP LOGS INDICATED A NUMBER OF STALLS DATING BACK TO (B)(6) 2013. NO PATIENT SYMPTOMS WERE REPORTED. THIS DEVICE SYSTEM DELIVERED LIORESAL. REPORTEDLY, THE PATIENT WAS TO HAVE A PUMP REPLACEMENT ON (B)(6) 2013. HOWEVER, INFORMATION LATER RECEIVED INDICATED THAT A REVISION OCCURRED ON (B)(6) 2013. THERE WAS NO PATIENT INJURY AND THE DEVICE SYSTEM REPORTEDLY DELIVERED COMPOUNDED BACLOFEN. FURTHER REPORTED, THE PUMP APPEARED TO HAVE WORKED FOR THE PATIENT INITIALLY. HOWEVER, THE PATIENT REPORTED THAT THE PUMP 'DOES NOT HELP ME ANYTHING.' APPROXIMATELY, TWO YEARS AFTER THE PUMP WAS IMPLANTED THE TRIGEMINAL NERVE PAIN IN THE PATIENT'S MOUTH RETURNED. A GAMMA LASER WAS USED TO TREAT THIS PAIN AT SOME POINT; HOWEVER, THE PATIENT HAD ALSO BEEN MEDIATED FOR THIS. PRIOR TO THE PUMP REPLACEMENT THE PAIN WAS 'VERY SERIOUS' AGAIN. HOWEVER, ONCE THE PUMP WAS REPLACED THE PAIN WENT AWAY AND THE PATIENT WAS CONCERNED THAT THE PUMP HAD MALFUNCTIONED. FURTHER INFORMATION WAS RECEIVED WHICH INDICATED THE PUMP WAS REPLACED ON (B)(6) 2013 DUE TO RECURRENT STALLS. THE PATIENT HAD RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183100 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention