BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5239671 · Received November 20, 2015

    Report

    Report Number
    3004209178-2015-23202
    Event Type
    Injury
    Date Received
    November 20, 2015
    Report Date
    November 6, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODCUCTS: PRODUCT ID: 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS LATER RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA CLINICAL STUDY INDICATING THAT ON 2016-(B)(6) EXAMINATION/PALPATION REVEALED WELL HEALED INCISIONS ALONG THE MIDLINE LUMBAR SPINE AND OVER THE ABDOMEN WHERE THE PATIENT'S PREVIOUS INTRATHECAL PUMP RESERVOIR HAD BEEN LOCATED. THE EVENT WAS RESOLVED WITHOUT SEQUELAE.

    Description of Event or Problem · 1

    ON 2015-12-01, ADDITIONAL INFORMATION FROM THE HEALTHCARE PROVIDER (HCP) REPORTED THAT, FOLLOWING THE PREVIOUSLY REPORTED PUMP EXPLANT, THAT THE DEVICE WAS NOT REPLACED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA IMPLANTABLE SYSTEMS PERFORMANCE REGISTRY (ISPR), REGARDING A PATIENT WHO WAS RECEIVING DILAUDID 25.0 MG/ML; 7.689 MG/DAY AND FENTANYL 1.0 MG/ML; 0.3075 MG/DAY VIA AN IMPLANTABLE PUMP IN SIMPLE CONTINUOUS MODE FOR SPINAL PAIN. IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT HAD A PIN HOLE OPENING IN THE PUMP INCISION AND EXPERIENCED DRAINAGE FROM SEROMA. ON (B)(6) 2014 EXAMINATION/PALPATION REVEALED THAT THE PATIENT NOTED CLOUDY FLUID FROM SEROMA DRAINAGE. AS OF (B)(6) 2015, THE PATIENT NOTED THAT HE STILL CONTINUED TO HAVE SEROMA WITH DRAINAGE AT THE SITE OCCASIONALLY. INFORMATION WAS LATER RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A CLINICAL STUDY. THE SEROMA WAS DRAINED ON (B)(6) 2014. A PHYSICAL EXAM WAS PERFORMED ON (B)(6) 2015 AND THERE WERE NO SIGNS OF SWELLING OR FLUID NOTED. PER PATIENT, EXAMINATION/PALPATION REVEALED THAT FLUID STILL PERIODICALLY DRAINS FROM THE HOLE. ON (B)(6) 2015 INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL (HCP) VIA A CLINICAL STUDY, CONSUMER AND A COMPANY REPRESENTATIVE. THE PATIENT HAD ONGOING ISSUES WITH DRAINAGE FROM A PINHOLE IN HIS INCISION. THE PATIENT HAD BEEN CLEANSING THE AREA WITH ALCOHOL AND HYDROGEN PEROXIDE AND USING TOPICAL ANTIBIOTIC. THE PATIENT FOLLOWED UP WITH THE HCP ON (B)(6) 2015 AND EXAMINATION NOTED EXCORIATION ALONG THE LATERAL SIDE OF THE PUMP RESERVOIR. THERE WAS A LARGE AMOUNT OF PURULENT DRAINAGE. THE PATIENT REPORTS A FIRM, TENDER ELONGATED LUMP TRACKING, ONE INCH IN WIDTH, TRACKING FROM LOWER ABDOMEN (PUMP RESERVOIR) AROUND TO LUMBAR SPINE. THE DRAINAGE WAS GREENER, MORE CONSTANT AND PURULENT. THE PATIENT HAD SIGNS THAT WERE STRONGLY SUGGESTIVE OF INFECTION. THE HCP WANTED TO ADMIT HIM TO THE HOSPITAL ON THE SAME DAY BUT THE PATIENT REFUSED. ON (B)(6) 2015 THE PATIENT WAS ADMITTED FOR A PUMP INFECTION AND EXPLANT OF THE PUMP. THE PATIENT EXPERIENCED A SEVERE INFECTION ANTERIOR INTO THE PUMP POCKET. THE PUMP WAS EXPLANTED (B)(6) 2015. ON (B)(6) 2015 DURING SURGICAL OBSERVATION A LARGE AMOUNT OF PURULENT MATERIAL WAS IN THE PUMP POCKET. THERE WAS SLUGGISH FLOW OF CEREBROSPINAL FLUID (CSF) WHEN THE CATHETER WAS CUT. A WOUND VAC WAS PLACED DURING THE EXPLANT SURGERY. A SURGICAL REVISION WAS PERFORMED TO CUT THE CATHETER AND REMOVE THE PUMP SEGMENT. THE INTRATHECAL SEGMENT WAS LEFT IN PLACE. LAB WORK ON (B)(6) 2015 CONSISTED OF A CULTURE OF PURULENT MATERIAL FROM THE POCKET THAT GREW (B)(6). THE PATIENT WAS GIVEN INTRAVENOUS (IV) ANCEF AND ORAL MORPHINE SULFATE WAS INITIATED (B)(6) 2015. ON (B)(6) 2015 A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE PLACEMENT OCCURRED FOR CONTINUED INTRAVENOUS (IV) ANTIBIOTIC ADMINISTRATION A SURGICAL REMOVAL AND REPLACEMENT OF WOUND VAC WAS ON (B)(6) 2015. THE OUTCOME WAS ONGOING. THE LOCATION OF THE ISSUE WAS THE INCISIONAL SITE/DEVICE TRACT. THE EVENT WAS RELATED TO THE DEVICE/THERAPY AND POSSIBLY RELATED TO THE IMPLANT PROCEDURE. THE SEVERITY OF THE EVENT WAS NOTED AS MILD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770281 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Hospitalization| R