BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3200555 · Received July 1, 2013

    Report

    Report Number
    3004209178-2013-11151
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 2, 2013
    Report Date
    June 6, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1579-2013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: CATHETER MODEL: 8578, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: UNK; CATHETER MODEL: 8731, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: UNK. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED A MOTOR FEEDTHRU ANOMALY; SHORTING ACROSS INSULATOR.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED AS OF THE DATE OF THIS REPORT THAT THE PUMP ALARM WAS NOT HEARD BUT CONFIRMED BY TELEMETRY AS A CRITICAL ALARM WITH THE MESSAGE OF ¿STOPPED PUMP MAY EXCEED TUBE SET.¿ A CONFIRMED MOTOR STALL NOTED IN EVENT LOGS WITH NO MOTOR STALL RECOVERY WAS NOTED. PER REPORTER PATIENT HAD MULTIPLE STALLS THE MORNING OF (B)(6) 2013 AND NO RECOVERY WAS NOTED ON THE LAST STALL ON (B)(6) 2013. IT WAS ADDED THAT THEY WERE TO ADMIT PATIENT TO THE HOSPITAL. PATIENT WAS NON-VERBAL. IT WAS REPORTED THAT PATIENT WAS VERY SPASTIC THIS TIME BUT WAS JUST LOOKING AROUND AS HE DID AT THE LAST APPT. IT WAS LATER REPORTED ON THE SAME DAY THAT THERE WERE SENDING PATIENT TO ER. THEY WERE TO GET PATIENT ON ORAL MEDICATIONS, AS WELL. THEY NEEDED PROGRAMMING ASSISTANCE ON SETTING PUMP TO MINIMUM RATE MODE IN CASE IT WOULD START BACK UP. IT WAS REPORTED THAT THE PATIENT HAD BEEN 4 DAYS SINCE GETTING DRUG AND THAT PATIENT MAY OR MAY NOT HAVE SYMPTOMS AS IT WAS DIFFICULT TO TELL BECAUSE THE PATIENT WAS MENTALLY DISABLED. DRUG DELIVERED VIA THE DEVICE WAS BACLOFEN 2000 MCG/ML AT A DAILY DOSE OF 404 MCG/DAY. THE NEXT DAY IT WAS CONFIRMED THAT PATIENT WAS TAKING TO THE ER WITH A PUMP ALARM, AND STARTED ON ORAL BACLOFEN ON (B)(6) 2013. PER THE REFILL NURSE THE PATIENT WAS SIGNIFICANTLY MORE SPASTIC THAN USUAL DESPITE THE NURSING HOME REPORT THAT THE PATIENT SEEMED UNCHANGED TO THEM. MANAGING PHYSICIAN WAS TO CONTACT THE NURSING HOME FOR INCREASE ORAL BACLOFEN DOSE AND ORAL VALIUM DOSE AS NEEDED UNTIL THE PUMP COULD BE REPLACED. THE IMPLANTING PHYSICIAN WAS OUT OF TOWN TILL (B)(6) 2013. FURTHER FOLLOW-UP INDICATED MOTOR STALLS X3 WITH RECOVERY AND THEREAFTER PERMANENTLY STALLED; IT WAS FOUND STALLED ON THE REFILL DATE X2 DAYS. NO SIGNIFICANT SIDE-EFFECTS, SLIGHTLY MORE SPASTIC. PATIENT WAS NOT HOSPITALISED BUT SENT TO THE ER. PATIENT WAS IMMEDIATELY PLACED ON BACLOFEN VIA GASTRIC TUBE AND VALIUM AS WELL. THE PUMP WAS REPLACED LATER. PATIENT OUTCOME WAS NOTED AS NO- INJURY/NON-SERIOUS ILLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298654 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention