BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3181743 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10687
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 28, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, LOT# N262770001, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT AT A REFILL ON (B)(6) 2013 A PUMP VOLUME DISCREPANCY OCCURRED. THE ACTUAL RESIDUAL VOLUME (ARV) OF 10ML WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME (ERV) OF 4.9ML. THE PATIENT EXPERIENCED A LOT OF SPASMS; THE PATIENT HAS THEM DAILY/FREQUENTLY. THE PATIENT ¿ACTUALLY FOLDS OVER IN WHEELCHAIR WITH A PAINFUL SPASM THAT LASTS FOR MINUTES.¿ HCP WILL CONTINUE TO MONITOR THE VOLUME DISCREPANCY. THE DOSE WAS INCREASED AND HCP WILL MONITOR FOR PATIENT RESPONSE. HCP CONSIDERED USING BACLOFEN TO HELP WITH PATIENT SPASMS AND PAIN.

    Description of Event or Problem · 1

    A REPRESENTATIVE REPORTED THAT, AT A PATIENT¿S REFILL, THE PHYSICIAN ASPIRATED 16.5 CC¿S OF MEDICATION, AND THE RESIDUAL VOLUME WAS SUPPOSED TO BE 2.2 CC¿S. THE PATIENT DID NOT SEE ANY CHANGE IN THEIR SYMPTOMS. THE PHYSICIAN WANTED TO ¿LEAVE IT THE WAY IT WAS¿ AND NO INCREASE THE PATIENT¿S DOSAGE. THE PATIENT REQUESTED THAT HE ¿BUMP IT UP¿. THE PROGRAMMING WAS LEFT THE SAME SINCE THIS WAS THE FIRST DISCREPANCY NOTED. THE PATIENT WAS TO BE SEEN AGAIN IN FIVE OR SIX WEEKS TO CHECK THE VOLUMES. NO FURTHER ISSUES WITH THE REFILL WERE NOTED. THE PATIENT WAS NOTED TO HAVE COMPLAINED ABOUT A ¿SPOT ON HIS BACK THAT WAS REALLY PAINFUL¿ AND THE PHYSICIAN THOUGHT ¿MAYBE IT WAS ANCHORS FROM THE SKIN¿. THEIR PHYSICIAN STATED ¿IF THEY NEEDED TO GO IN AND DO ANYTHING WITH THE CATHETER, THEY COULD TAKE THE ANCHORS OUT¿. THE REPRESENTATIVE FURTHER STATED THAT THEY THOUGHT IT WAS THE ¿STIM ANCHORS¿ AS THE PATIENT WAS NOTED TO HAVE HAD A NEUROSTIMULATOR IMPLANTED. THE PATIENT¿S PHYSICIAN STATED THEY THOUGHT IT WAS UNUSUAL THEY COULD FEEL THE CATHETER ON THE BACKSIDE SOMEWHERE. THE PATIENT WAS NOTED TO BE A THIN GUY. THE MEDICATIONS USED WITHIN THE SYSTEM WERE HYDROMORPHONE AND BUPIVACAINE. THE FOLLOWING DAY, THE REPRESENTATIVE REPORTED THAT PATIENT STILL HAD LEADS IMPLANTED FROM THE INS. THE PHYSICIAN SUSPECTED THAT THE PAIN IN THE PATIENT¿S BACK ¿MAY BE FROM THE ANCHOR IRRITATING THE TISSUE¿. IT WAS NOTED TO BE A MINOR DISCOMFORT, AND THERE WAS NO REASON TO SUSPECT ANY OTHER REASON THIS. THE DISCREPANCY WAS NOTED TO BE ¿VERY MINOR¿, BUT EXACT NUMBERS WERE NOT PROVIDED. IT WAS UNCLEAR WHY THE DISCREPANCY WAS NOTED TO BE ¿MINOR¿ WHEN CALCULATIONS FOUND IT TO BE OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT WAS CHECKED ON THE DATE OF THIS REPORT FOR VOLUME ACCURACY. THE EXPECTED VOLUME WAS 25 MILLILITERS (ML) AND THE ACTUAL WAS 26 ML. THE PUMP LOGS WERE CHECKED WITH NO ANOMALIES OR ALARMS. THE PATIENT WAS HAVING SOME INCREASED PAIN SO THE HYDROMORPHONE DOSE WAS INCREASED TO 0.85 MILLIGRAMS PER DAY. REPORTEDLY, THE INCREASE IN PAIN COULD BE DUE TO OTHER ISSUES THE PATIENT WAS EXPERIENCING WITH DEHYDRATION AND A URINARY TRACT INFECTION. THE SPECIFIC CAUSE OF THE PREVIOUS DISCREPANCY WAS NEVER FOUND BUT THE PUMP WILL BE MONITORED AT FUTURE REFILLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283282 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR