BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3852099 · Received June 5, 2014

    Report

    Report Number
    3004209178-2014-10217
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    February 17, 2014
    Report Date
    May 13, 2014
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8835, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2014 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE INCISION WAS CLEAN, DRY, INTACT AND HEALING WELL. THE WOUND EDGES ARE WELL APPROXIMATED. NO ERYTHEMA, TENDERNESS OR DRAINAGE NOTED AS OF (B)(6) 2014. IT WAS REPORTED THAT THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT, AS OF (B)(6) 2014, THE EDGES OF THE WOUND WERE NOT WELL APPROXIMATED ALONG THE OUTER THIRD OF THE ABDOMINAL INCISION. THERE WAS CLEAR, SEROUS DRAINAGE EMANATING FROM THE REGION AND IT WAS TENDER. TWO DAYS LATER, ESCHAR WAS EXCISED FROM THE PUMP POCKET. ONE WEEK AFTER THAT, IT WAS SEEN THAT ERYTHEMA WAS SURROUNDING THE ABDOMINAL INCISION WITH SEROSANGUINEOUS DRAINAGE. IN ADDITION, LAB WORK WAS PERFORMED AND THE RESULTS SHOWED THE CBC (COMPLETE BLOOD COUNT) WITH WBC (WHITE BLOOD CELL) COUNT AT 12.9, CRP (C-REACTIVE PROTEIN) AT 1.5, AND SEDIMENTATION RATE AT 29. AT THAT TIME, THE PATIENT WAS STARTED ON 300MG ORAL CLINDAMYCIN CAPSULES FOUR TIMES PER DAY OVER SEVEN DAYS. ONE WEEK FOLLOWING THAT, THE PATIENT WAS STARTED ON SEPTRA DS TWICE PER DAY OVER TEN DAYS AND BEGAN USE OF AN ABDOMINAL BINDER WITH CONTINUED WOUND CARE. AFTER THREE WEEKS, A SURGICAL REVISION WAS PERFORMED TO SPLICE THE CATHETER AND MOVE THE PUMP BOTH MEDIALLY AND SUPERIORLY IN THE CURRENT POCKET LOCATION TO REDUCE THE TENSION ON THE INCISION. IN ADDITION, LARGE AMOUNTS OF THICK INFLAMMATORY TISSUE WERE REMOVED FROM THE PUMP POCKET.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THERE WAS A WOUND INFECTION. THE RIGHT ABDOMINAL INCISION WAS NOT WELL APPROXIMATED; THERE WAS ERYTHEMA AND SMALL AMOUNT OF DRAINAGE FOUND DURING EXAMINATION/PALPATION ON 2014 (B)(6). LAB RESULTS ON 2014 (B)(6) WERE WHITE BLOOD COUNT (WBC) HIGH (14.2), SED RATE HIGH (38) CRP HIGH (3.24). INTERVENTIONS INCLUDED MEDICAL OR NON-SURGICAL THERAPY THAT INCLUDED APPLYING STERI-STRIPS TO THE RIGHT ABDOMINAL INCISION, ORAL ANTIBIOTICS (CLINDAMYCIN 300MG ORALLY FOUR TIMES DAILY FOR SEVEN DAYS) ON 2014 (B)(6). ON 2014 (B)(6) THERE CONTINUED TO BE REDNESS TO THE RIGHT ABDOMINAL INCISION. THE PATIENT REPORTED THAT THEY DID NOT TAKE THE CLINDAMYCIN BECAUSE THEY STARTED FEELING BETTER. THERE WAS A MEDICATION ADJUSTMENT; PATIENT WAS INSTRUCTED TO TAKE ANTIBIOTIC REGIMEN. DURING EXAMINATION/PALPATION ON 2014 (B)(6) THE RIGHT ABDOMINAL INCISION WAS WELL APPROXIMATED; NO ERYTHEMA, WARMTH, EDEMA, OR DRAINAGE. ETIOLOGY WAS REPORTED AS NOT RELATED TO DEVICE OR THERAPY BUT RELATED TO IMPLANT PROCEDURE. THE EVENT RESOLVED WITH SEQUELAE ON 2014 (B)(6), SEQUELA WAS THE WOUND DRAINAGE. SEVERITY WAS REPORTED AS MILD. IT WAS REPORTED THAT THE PUMP WAS IN SHELF STATE. IT WAS REPORTED THAT DURING EXAMINATION AND PALPATION ON 2014 (B)(6), THERE WAS CLEAR DRAINAGE COMING FROM THE RIGHT ABDOMINAL INCISION. IT WAS NOTED THAT THERE WAS MEDICAL OR NON-SURGICAL THERAPY INTERVENTION. INTERVENTIONS INCLUDED DEBRIDEMENT OF THE TOP LAYERS OF ESCHAR TO RIGHT ABDOMINAL INCISION, CONTINUED APPLICATION OF NEOSPORIN OINTMENT AND HAD THE INCISION COVERED WITH GAUZE BANDAGE ON 2014 (B)(6). DURING EXAMINATION AND PALPATION ON 2014 (B)(6) THE RIGHT ABDOMINAL INCISION CONTINUED TO HAVE CLEAR DRAINAGE. MEDICAL OR NON-SURGICAL INTERVENTION INCLUDED CONTINUED CLEANING OF THE WOUND WITH ALCOHOL FOUR TIMES A DAY AND KEPT IT COVERED WITH DRESSING AS PATIENT WAS DOING AT HOME. ETIOLOGY WAS REPORTED AS BEING RELATED TO IMPLANT PROCEDURE AND UNLIKELY RELATED TO DEVICE OR THERAPY. IT WAS NOTED THAT THE EVENT WAS ONGOING. SEVERITY WAS REPORTED AS MILD. THE PUMP WAS DELIVERING MORPHINE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT PATIENT WAS ADMITTED FOR 24 HOUR OBSERVATION FOR INTRAVENOUS ANTIBIOTICS ON 2014 (B)(6) DUE TO WOUND INFECTION THAT NEEDED TO BE MANAGED AGGRESSIVELY. WOUND HAD DEHISCED AT MIDLINE. ON 2014 (B)(6) SURGICAL REVISION WAS DONE; THE ANTERIOR WOUND EXPLORATION WAS DONE ALONG WITH WASH OUT AND WOUND CLOSURE. DURING PROCEDURE, IT WAS OBSERVED THAT THERE WAS DRAINAGE FROM THE RIGHT ABDOMINAL INCISION, SOME INFLAMMATORY TISSUE OVER THE PUMP AND SUPERFICIAL SKIN BREAKDOWN. PATIENT WAS STARTED ON CLINDAMYCIN 150MG ¿2¿ FOUR TIMES A DAY FOR 7 DAYS. ON 2014 (B)(6), EXAMINATION/PALPATION WAS DONE AND IT WAS NOTED THAT THE AREA HAD SOME ESCHAR THEREFORE INTERVENTION INCLUDED WASHING OFF THE ESCHAR, EXISTING STABLES WERE REMOVED AND 2-3 MORE STABLES WERE APPLIED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2015. ON (B)(6) 2015, IT WAS NOTED THAT DURING EXAMINATION AND PALPATION THE SKIN WAS INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329468 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention