BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4173729 · Received October 15, 2014

    Report

    Report Number
    3004209178-2014-19726
    Event Type
    Injury
    Date Received
    October 15, 2014
    Report Date
    September 22, 2014
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CATHETER, MODEL 8596SC; SERIAL # (B)(4); EXPLANT DATE: (B)(6)-2014. CATHETER, MODEL 8709; SERIAL # (B)(4); EXPLANT DATE: (B)(6)-2014. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE CATHETER PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2004 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER RECEIVED REPORTED THE PATIENT WAS SEEN ON (B)(6). THE PATIENT HAD SIGNIFICANT TENDERNESS, REDNESS AND PAIN. THERE WAS NO MENTION ON THE SUTURES BEING BUSTED OPEN AT ALL. THE PATIENT WAS REFERRED TO A GENERAL SURGEON AS THE PATIENTS UROLOGIST HAD CONCERNS THAT MAYBE THERE WAS BLADDER EROSION AND THE HCP THOUGHT THE PUMP POCKET MAY BE INFECTED. THE HCP RECOMMENDED THE PUMP AND CATHETER BE REMOVED. THE PUMP AND CATHETER WERE REMOVED DUE TO A FUNGAL INFECTION OF THE POCKET AND PER THE REPORTER THERE WAS NO ¿GENERAL SURGEON¿. ONE OF THE MANAGING HCP HAD NO INFORMATION ABOUT THE BLADDER BUT INDICATED NO ONE MADE MENTION OF ANY BLADDER ISSUE. THE MANAGING HCP HAVE NOT SEEN THE PATIENT SINCE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION LATER REPORTED THE SYMPTOMS THE PATIENT EXPERIENCED WERE ABDOMINAL PAIN, RED AROUND THE PUMP, PUMP TILTED DOWNWARDS, AND SHARP STABBING FEELING. TROUBLESHOOTING INCLUDED SCANNING THE PUMP, THE PCP (PRIMARY CARE PHYSICIAN) PUT THE PATIENT ON ANTIBIOTIC FOR A UTI (URINARY TRACT INFECTION). THE PATIENT WAS SEEN ON (B)(6) 2014 AND WAS ADVISED TO KEEP THEIR APPOINTMENT WITH THE SURGEON ON (B)(6) 2014, (ALREADY HAD AN APPOINTMENT). PER THE MANAGING HCP THE POSITIONING OF THE DEVICE WAS CORRECTED, NOT BY THEIR OFFICE, SEEN BY THE SURGEON. PER THE HCP IT WAS UNKNOWN HOW THE PATIENT WAS DOING NOW, THE PATIENT HAS FOLLOW-UP APPOINTMENT, HAS BEEN SEEING THE SURGEON.

    Description of Event or Problem · 1

    PER THE OPERATIVE NOTES FROM (B)(6) 2014, THE PATIENT WAS TAKEN INTO SURGERY FOR ¿BACLOFEN PUMP WOUND INFECTION¿. THE PROCEDURE PERFORMED ON THAT DATE WAS ¿REMOVAL OF INTRATHECAL CATHETER¿. THE PATIENT HAD PRESENTED TO THE HOSPITAL ON (B)(6) 2014 FOR A PLANNED REVISION OF THE PUMP, BUT WAS FOUND TO HAVE A LIKELY INFECTED FLUID POCKET. CULTURES WERE COLLECTED FROM THE FLUID POCKET AND ULTIMATELY GREW OUT 1+ YEAST WHICH PROMPTED THEM TO THEN REMOVE THE REMINDER OF THE CATHETER FOR INFECTIOUS CONTROL REASONS. UPON OPENING THE BACK INCISION TO REMOVE THE CATHETER, GREEN, CLOUDY DISCHARGE SIMILAR TO THAT NOTED AT THE ABDOMINAL POCKET WAS NOTED IN THE SUPRAFASCIAL AND SUBFASCIAL SPACES; MICROBIOLOGICAL SPECIMENS OF BOTH WERE COLLECTED. THE INTRATHECAL PORTION OF THE CATHETER WAS EASILY RETRIEVED. THERE WAS NO LEAKAGE SEEN AFTER OVER-SEWING THE CATHETER ENTRY SITE. AFTER REMOVING THE INTRATHECAL PORTION OF THE CATHETER, THEY ATTEMPTED TO REMOVE THE REMAINDER OF THE CATHETER FROM THE SPINAL INCISION BY PULLING THE ABDOMINAL PIECE THROUGH THE BACK INCISION. HOWEVER, UPON PULLING THE CATHETER, IT SNAPPED, SO THEY OPENED THE ABDOMINAL PORTION OF THE INCISION, EASILY IDENTIFIED THE REMAINDER OF THE CATHETER, AND EASILY REMOVED IT. THE SUBFASCIAL AND INTRATHECAL PORTIONS OF THE CATHETER WERE BOTH SENT FOR MICROBIOLOGICAL STUDIES. BOTH INCISIONS WERE IRRIGATED AGGRESSIVELY USING BACITRACIN-INFUSED SALINE AND THE INCISIONS WERE CLOSED. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

    Description of Event or Problem · 1

    APPROXIMATELY 2-3 MONTHS AGO, THE PATIENT¿S PUMP TURNED SIDEWAYS. APPROXIMATELY 2 WEEKS PRIOR TO THIS REPORT, THE ¿INCISION BUSTED OPEN¿. THE PATIENT SAW HIS PHYSICIAN ON THE DATE OF THIS REPORT. THE PHYSICIAN FELT THAT THE PUMP MAY BE ERODING INTO THE BLADDER. THE PHYSICIAN RECOMMENDED THAT THE PATIENT HAVE A GENERAL SURGEON REMOVE THE ¿SHUNT¿ AND CATHETER. THE PATIENT WAS TO BE REFERRED TO A GENERAL SURGEON. THE DEVICE SYSTEM WAS DELIVERING BACLOFEN. THE OUTCOME WAS NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654202 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Life Threatening| R