BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1082996 · Received July 28, 2008

    Report

    Report Number
    3004209178-2008-04453
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    August 17, 2007
    Report Date
    July 1, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    PENDING
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYNCHROMED II PUMP SERIAL NUMBER IS WITHIN THE SUSPECTED POPULATION OF INFUSION DEVICES THAT ARE POTENTIALLY MISSING PROPELLANT AS DESCRIBED IN MEDTRONIC'S PHYSICIAN LETTER. (SYNCHROMED II MISSING PROPELLANT RECALL, Z# PENDING).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ALL PREVIOUSLY REPORTED PATIENT AND DEVICE CODES WILL BE UPDATED/CORRECTED TO THE FOLLOWING FOR THIS EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    PUMP ANALYSIS REVEALED AN INFUSION ANOMALY, INFUSION TESTS WERE HIGH ON SEVERAL TESTS. CATHETER ANALYSIS REVEALED NO SIGNIFICANT ANOMALIES; ACCEPTABLE CATHETER TESTING (PUMP CONNECTOR AND 33 CM PROXIMAL CATHETER RETURNED).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE HCP WAS UNABLE TO WITHDRAW ANY MEDICATION OUT OF THE PUMP RESERVOIR AT TWO PREVIOUS REFILLS. THE VOLUME WAS LESS THAN EXPECTED; THE EXPECTED RESERVOIR VOLUME WAS 7.5 ML WHILE THE ACTUAL RESERVOIR VOLUME WAS 0ML. AT SUBSEQUENT REFILLS, THE HCP EXPECTED APPROX 3-5ML, BUT THE PUMP WAS EMPTY EACH TIME. THE PUMP WAS FILLED WITH 40 ML AT REFILL; THE HCP DID NOT REPORT ANY DIFFICULTY FILLING THE PUMP WITH 40 ML. THE PT EXPERIENCED "LESS EFFECT" OVER THE LAST MONTH OR SO. THE REPORTED SYMPTOMS WERE WORSENING SPASTICITY AND DYSTONIA. THE REPORTED VOLUME DISCREPANCY WOULD INDICATE THAT THE PT WAS GETTING MORE DRUG THAN INTENDED, NOT LESS. THE HCP FILLED THE PUMP WITH 20ML OF PRESERVATIVE-FREE SALINE. HE THEN ASPIRATED 19 ML FROM IT THE NEXT DAY TO MAKE CERTAIN THAT THE PUMP RESERVOIR WAS COMPLETELY EMPTY AND TO VERIFY THAT THE NEEDLE WAS IN THE PUMP RESERVOIR. THE HCP THEN REFILLED THE PUMP WITH 40ML OF 2000 MCG/ML DRUG AND DAILY DOSE OF 500MCG/DAY. THE HCP PLANNED TO HAVE THE PT RETURN TO CLINIC AFTER 2 WEEKS TO CHECK FOR VOLUME DISCREPANCY AGAIN.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE CATHETER TIP AND FELT LIKE THE "CATHETER IS PUTTING PRESSURE ON A NERVE." THE HCP PERFORMED X-RAYS AND DID NOT SEE AN ISSUE WITH COMPONENTS. THE HCP CONTINUED TO HAVE DIFFICULTY WITHDRAWING ALL OF THE MEDICATION OUT OF THE PUMP. THE NEXT REFILL WAS SCHEDULED FOR (B)(6) 2008. IT WAS LATER REPORTED THAT THE VOLUME DISCREPANCY WAS < 25%. NO OTHER COMPLICATIONS WERE NOTED DURING THE REFILL. THE MANUFACTURER'S REPRESENTATIVE BELIEVED THAT THERE WAS NO ISSUE WITH THE PUMP BUT IT MAY BE RELATED TO THE FACT THAT DIFFERENT PERSONNEL HAVE PERFORMED THE REFILLS.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE HCP HAS "REPEATEDLY" HAD LESS PUMP RESERVOIR VOLUME THAN EXPECTED. THE HCP HAD PLANNED EARLY REFILLS APPROXIMATELY 3 WEEKS PRIOR TO ALARM DATE. THE PUMP CONTAINED COMPOUNDED BACLOFEN 2000 MCG/ML AT A DAILY DOSE OF 450 MCG. THE PATIENT NOTED INCREASED SPASTICITY JUST BEFORE REFILL. THE HCP WAS UNCERTAIN OF THE REASON FOR THE PAIN AT THE CATHETER SITE. THE PATIENT EXPERIENCED A "SUDDEN ONSET" OF INCREASED MYOTONIA (B)(6) 2008. THE HCP WAS UNABLE TO GET XRAYS DUE TO THE DYSTONIA. THE PATIENT WAS BEING SCHEDULED FOR A DYE STUDY. THE PATIENT WAS CONCERNED THAT THERE MIGHT BE SOMETHING WRONG WITH THE CATHETER. STATED THAT THE HCP JUST WANTED TO REPLACE THE PUMP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE PATIENT REPORTED THAT HER CATHETER "RUPTURED" AND SHE WAS GOING TO HAVE IT REPLACED. SHE STATED THAT HER PHYSICIAN SAID THAT THIS WAS DUE TO THE BEND OF HER BODY AND SHE WOULD HAVE THE PUMP PLACED IN HER BACK (INSTEAD OF HER ABDOMEN) TO RELIEVE THIS ISSUE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THE PATIENT HAD THE SYSTEM EXPLANTED ON (B)(6) 2008. THE HCP CHOSE AN ALTERNATIVE THERAPY THE DRUG IN THE PUMP WAS LIORESAL. THE PATIENT RECOVERED WITHOUT SEQUEL.

    Description of Event or Problem · 1

    IT WAS ALSO REPORTED THAT THE PATIENT ALSO EXPERIENCED HEADACHE. THE PUMP CONTAINED COMPOUNDED BACLOFEN PER THE HCP, CONCENTRATION AND DAILY DOSE NOT REPORTED. ON (B)(6) /2008, THE HCP BEGAN "WEANING DOWN HER BACLOFEN IN A RELATIVELY RAPID FASHION". PER THE REPORTER, SURGICAL "EXPLAIN / IMPLANT" OF THE PUMP AND CATHETER TOOK PLACE ON (B)(6) 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention EXPLANTED| ACCESSORY MODEL 8590-1| EXPLANTED| PROGRAMMER MODEL 8840| CATHETER MODEL 8709