BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2191764 · Received July 22, 2011

    Report

    Report Number
    3004209178-2011-05692
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    May 12, 2011
    Report Date
    July 1, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO ANOMALY, NORMAL DEVICE FUNCTION. THE RETURNED CATHETER HAD DARK RESIDUE OCCLUSION IN DISPENSING HOLES AND A SLICE CUT (LIKELY TO BE USER RELATED) WAS FOUND 64 CM FROM PUMP CONNECTOR.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT SAW THEIR PHYSICIAN YESTERDAY AND THE PUMP WAS ASPIRATED. THERE WAS NO OBSTRUCTION OR BLOOD. A PUMP STUDY WAS GOING TO BE SCHEDULED NEXT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT PATIENT HAD EXPERIENCED TWO OBSTRUCTIONS BETWEEN (B)(6) 2011 AND A CATHETER DYE STUDY WAS DONE BACK THEN (REPORTED PREVIOUSLY IN THE INITIAL REPORT) AND NO OBSTRUCTIONS WERE FOUND AT THAT TIME. ON (B)(6) 2011 IT WAS STATED THAT THE PATIENT'S SURGEON CHECKED THE CATHETER AND NO OBSTRUCTIONS WERE FOUND, BUT THE CATHETER WAS OBSERVED TO BE LOOSE AND THE SURGEON TIGHTENED IT AT THAT TIME. ABOUT TWO WEEKS AFTER THAT IN (B)(6) PATIENT HAD ANOTHER OBSTRUCTION. AT THAT TIME PATIENT'S HCP AGAIN TRIED USING THE SYRINGE AND INITIALLY GOT NOTHING PULLED BACK BUT THEN WAS "ABLE TO GET SOMETHING AFTER SOME CLOTS". THE PATIENT HAD A COUPLE MORE REDUCTIONS IN (B)(6) 2011 AND WAS DOING FINE UP UNTIL THE (B)(6) 2012. SHE WAS DUE FOR A REFILL ON (B)(6) 2012 AND DURING HER REFILL HCP EXPERIENCED AN "ERROR WITH HIS CLINICIAN PROGRAMMER". THE PATIENT WOKE UP THE NEXT DAY IN TREMENDOUS PAIN AND THOUGHT MAYBE SINCE THERE WAS AN ERROR DURING THE REFILL SESSION THAT SOMETHING MIGHT HAVE NOT UPDATED. THE PATIENT WENT BACK ON (B)(6) 2012 AND HCP CHECKED HER SETTINGS "WITH A DIFFERENT CLINICIAN PROGRAMMER BECAUSE IT WAS A DIFFERENT LOCATION AND EVERYTHING WAS FINE". THE PATIENT GOT RELIEF FOR ABOUT ONE DAY AND THEN THE "PAIN STARTED AGAIN LIKE SHE HAS NOW". A CATHETER DYE STUDY WAS PERFORMED ON (B)(6) 2012 AND CONCLUDED NO OBSTRUCTIONS. PRIOR TO THE DYE STUDY HCP HAD AGAIN USED A SYRINGE AND PUSHED SALINE THROUGH. WHEN HCP WAS PUTTING IN THE DYE DURING THE STUDY PATIENT WAS EXPERIENCING PAIN AROUND THE PUMP (FLANK) AREA AND HAD NEVER HAD THAT BEFORE. THE PATIENT WAS EXPERIENCING INCREASED BASELINE PAIN. THERE WERE NEVER ANY VOLUME DISCREPANCIES AT HER REFILLS OR ALARMS EITHER. ON (B)(6) 2012 PATIENT VISITED THE HCP AND A PUMP STUDY WAS PLANNED (REPORTED PREVIOUSLY IN FOLLOW UP REPORT #1). IT WAS LATER STATED THAT THE PATIENT WAS SCHEDULED FOR REPLACEMENT AS "CURRENT PUMP HASN'T WORKED PROPERLY MOST OF THE TIME SHE HAS HAD IT". THE PUMP AND CATHETER WERE REPLACED. IT WAS NOTED THAT A PUMP ROTOR STUDY WAS DONE, DETAILS WERE NOT PROVIDED. PATIENT SUSTAINED NO INJURY, RECOVERED WITHOUT SEQUEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT NEVER HAD THERAPEUTIC EFFECT SINCE THE PUMP REPLACEMENT, ESPECIALLY THERE WAS INCREASED BASELINE PAIN. PT WAS GETTING "NO PAIN RELIEF". THERE HAD BEEN NO CHANGES IN DRUG SUPPLIER, DRUG AND CONCENTRATION. A DYE STUDY WAS PERFORMED DURING WHICH IT WAS DIFFICULT TO ASPIRATE THROUGH CATHETER ACCESS PORT (CAP) BUT EVENTUALLY COULD ASPIRATE AND CONFIRM THAT CATHETER WAS PATENT. WHILE ASPIRATING THE PHYSICIAN FELT LIKE HE WAS PULLING A "CLOT" OUT OF THE CATHETER. FOLLOWING THIS THE PT EXPERIENCED POSITIVE THERAPEUTIC BENEFIT FOR ABOUT A WEEK AND THEN SYMPTOMS RETURNED. ASPIRATION WAS DONE ONCE AGAIN WITH SOME DIFFICULTY, PULLING OUT THE "CLOT" AND PT GOT PAIN RELIEF FOR ABOUT A WEEK. A THERAPEUTIC BOLUS WAS GIVEN. THE DRUGS INFUSED VIA THE PUMP INCLUDED DILAUDID 30MG/ML AND CLONIDINE, STATUS CURRENT. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention CATHETER: MODEL 8709, LOT # J12416R09| PROGRAMMER: 8840, SERIAL#: UNK.| EXPLANTED:| IMPLANTED: