BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3162526 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10141
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 17, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER; PRODUCT ID NEU_PTM_PROG, LOT# UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID NEU_UNKNOWN_PROG, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS RECEIVING A BOLUS DENIAL FROM THE PERSONAL THERAPY MANAGER (PTM). THE PATIENT WAS DENIED A BOLUS TWICE A COUPLE OF WEEKS PRIOR TO REPORT AND ALSO ON THE DAY OF REPORT, GIVING THE PATIENT THE 4 HOUR LOCKOUT INTERVAL EACH TIME. INFORMATION INDICATED A THE PATIENT MOST LIKELY DID RECEIVE THE BOLUS, BUT WOULD CONTACT THE HEALTHCARE PROVIDER (HCP) FOR A REPORT VERIFYING THAT THE BOLUS WAS RECEIVED. THE PATIENT ALSO INDICATED THAT THE PUMP WAS STICKING OUT SINCE THE PUMP¿S IMPLANT. THE PATIENT A BAND FOR THE LAST 8 WEEKS, AND THE PUMP WAS STILL STICKING OUT AND WOULD GET CAUGHT ON THE TABLE AND THE PATIENT ENDED UP WITH A ¿REAL GOOD SORE ON IT¿. THE PATIENT WAS GOING TO BE HAVING A REVISION SURGERY ON (B)(6) 2013. IT WAS LATER REPORTED THAT THE PUMP WAS ¿TIPPED¿ IN THE POCKET, AND AS A RESULT TELEMETRY BETWEEN THE PUMP AND BOTH THE PHYSICIAN PROGRAMMER AND THE PATIENT'S PTM COULD BE DIFFICULT. A PRINTED REPORT DID VERIFY THERE WERE SEVERAL INSTANCES OF A BOLUS BEING DELIVERED AND DENIED AT THE SAME TIME. IT WAS ALSO TAKING LONGER TO READ THE PATIENT¿S PUMP AND TO DELIVER THE BOLUSES. ALTHOUGH THE REPORT INDICATED THE PATIENT WAS GETTING THE BOLUS AND THIS WAS A COMMUNICATION ISSUE, THE PATIENT REPORTED NOT GETTING ANY PAIN RELIEF. IT WAS THE HOPE THAT THE REVISION ON (B)(6) 2013 FOR THE PARTIALLY FLIPPED PUMP WOULD RESOLVE THE ISSUE OF TELEMETRY. THE REPORTER ALSO NOTED THAT THE PUMP WAS TIPPED AND PROTRUDING SUCH THAT THE CATHETER COULD ALSO BE PALPATED. IT WAS LATER REPORTED THAT THE PATIENT¿S POCKET WAS REVISED BECAUSE THE PUMP WAS TILTED OUTWARD IN THE ABDOMEN AND CAUSING PAIN. IT WAS NOTED THAT IT WAS DIFFICULT JUST GETTING TELEMETRY TO THE PUMP PRIOR TO THE PROCEDURE. IT WAS DETERMINED BY READING THE PUMP LOGS, THE PATIENT INDEED DID GET THE BOLUSES REQUESTED AND BELIEVED TO HAVE BEEN DENIED. THE POCKET REVISION PROCEDURE WAS PERFORMED WITHOUT INCIDENT. THE CATHETER WAS INTACT, AND THE PUMP WAS REPOSITIONED IN THE POCKET AND SUTURED ON ALL 4 SUTURE LOOPS. THE PATIENT WAS TO GO HOME AND BEGIN USING THE PTM WHEN APPROPRIATE, AND IF THERE WERE ANY FURTHER BOLUS ISSUES, THE PATIENT WAS GOING TO CONTACT THE HCP. IT WAS LATER REPORTED THAT THAT DURING THE REVISION, IT APPEARED THE PUMP HAD ROTATED IN THE POCKET RATHER THAN FLIPPED, AND IT WAS OBVIOUS THAT THE SUTURES HAD NOT HELD. IT WAS ALSO REPORTED THAT THE PATIENT AGAIN RECEIVED A BOLUS DENIAL ON (B)(6) 2013 WITH THE 4 HOUR LOCKOUT INTERVAL, AGAIN SUGGESTING A COMMUNICATION ISSUE BUT THAT THE PATIENT DID MOST LIKELY RECEIVE THE BOLUS. THE PATIENT PLANNED TO DO FURTHER TROUBLESHOOTING, POSSIBLY REQUESTING THE BOLUS IN ANOTHER AREA OF THEIR HOME TO ELIMINATE ANY POSSIBLE INTERFERENCE IF PRESENT. THE PATIENT NOTED NOT FEELING ANY PAIN RELIEF WITH THE MOST RECENT BOLUS DENIAL AS WELL. THE PUMP WAS USED TO DELIVER BUPIVACAINE AND FENTANYL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT WAS SEEN BY THE HEALTHCARE PROVIDER (HCP) AND THE PUMP LOGS WERE READ. THE PATIENT WAS NOT DENIED HER BOLUSES. THE USE OF THE ANTENNA WAS REVIEWED WITH THE PATIENT AND SHE AGREED TO TRY USING HERS AGAIN. SINCE THAT VISIT, THE PATIENT NO LONGER HAD ANY PROBLEMS WITH BOLUS DENIALS. IT WAS ASSUMED THAT THE PATIENT WAS JUST HAVING TROUBLE WITH THE COMMUNICATION. AT THE TIME OF THE REPORT, THE PATIENT WAS DOING WELL AND WAS RECEIVING GOOD THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262587 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention