BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4163489 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19450
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 18, 2014
    Report Date
    October 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, FOR THE 3 DAYS PRIOR TO A REPORT ON (B)(6) 2014, THE PATIENT¿S SCIATIC NERVE HAD BEEN ¿DRIVING HER CRAZY¿. THE ONSET WAS GRADUAL. THE PATIENT¿S PAIN INCREASED FROM A PAIN LEVEL OF A 2, TO A 3, TO A 4 AND, AT THE TIME OF THIS REPORT, WAS AT A 7-8. THE PATIENT¿S BREAKTHROUGH MEDICATIONS WEREN¿T HELPING AND SHE WAS TAKEN OFF ORAL MORPHINE. THE PATIENT CALLED HER HEALTHCARE PROVIDER (HCP) ON (B)(6) 2014 AND HAD NOT HEARD BACK AS OF (B)(6) 2014. THE PATIENT HAD NOT HAD ANY FALLS OR TRAUMA. TWO DAYS AFTER THE PUMP WAS IMPLANTED, AN INCREASE WAS DONE AND ANOTHER INCREASE WAS PLANNED FOR (B)(6) 2014. IT WAS LATER REPORTED THAT, ONE WEEK AFTER SURGERY, THE PATIENT DEVELOPED AN INFECTION. IT WAS NOTED THAT, DURING SURGERY, THE PATIENT WAS GIVEN ¿RESOFREN¿ TWICE, ONCE DURING SURGERY AND ONCE 12 HOURS AFTER SURGERY. THE FIRST TIME THE PATIENT WENT BACK TO HER PHYSICIAN, SHE HAD AN INFECTION IN HER BACK. THE PATIENT WAS GIVEN ORAL ANTIBIOTICS FOR 10 DAYS. WHEN THE PATIENT WENT BACK TO HER PHYSICIAN THE FOLLOWING WEEK, IT LOOKED A LITTLE BETTER, BUT IT WAS STILL LEAKING. DETAILS AS TO WHAT WAS LEAKING WERE NOT REPORTED. THE PATIENT WENT BACK TO HER PHYSICIAN A THIRD TIME AND IT HAD STOPPED FOR A FEW DAYS, BUT THEN STARTED AGAIN. THE PATIENT WAS PRESCRIBED A SECOND ROUND OF ANTIBIOTICS AND WAS TOLD THAT IF IT DID NOT CLEAR, IT WOULD BE TAKEN OUT. DETAILS REGARDING WHAT WOULD BE TAKEN OUT WERE NOT REPORTED. THIS DISCUSSION OCCURRED ON APPROXIMATELY (B)(6) 2014. UNTIL (B)(6) 2014, THE PATIENT WAS DOING FINE. SHE HAD NO LEAKAGE, NEVER HAD A FEVER, AND HER BACK SITE LOOKED FINE. THE FRONT SITE ALSO LOOKED FINE, EXCEPT FOR ONE SMALL SPOT IN THE INCISION. THE SITE WAS VISIBLY ¿RUNNING¿. IT WAS NOT RUNNING CONSTANTLY BUT WHEN IT DID, IT SOAKED THE PATIENT. THE PATIENT FOUND THE SPOT BECAUSE IT SOAKED THROUGH TO HER SHORTS AND SHE PUT A PAD ON IT AND IT STILL SOAKED SOMEWHAT. IF THE PATIENT PUSHED ON THE AREA, IT CAME OUT. DETAILS REGARDING WHAT WAS RUNNING AND COMING OUT WERE NOT PROVIDED. THE PATIENT WAS PRESCRIBED A THIRD ROUND OF ANTIBIOTICS. THE PHYSICIAN SUGGESTED THAT THERE MAY HAVE BEEN AN INFECTION ON THE PUMP ITSELF. IT WAS NOTED THAT THE PATIENT HAD BEEN SLEEPING MORE, 12-16 HOURS PER DAY. THE PUMP WAS SCHEDULED TO BE REMOVED ON (B)(6) 2014 DUE TO THE INFECTION. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE. THE PATIENT¿S STATUS PRIOR TO THE EVENT, POSSIBLE DEVICE ISSUES, CAUSE OF THE EVENT, TROUBLESHOOTING/DIAGNOSTICS, AND FINAL PATIENT OUTCOME WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD DEVELOPED A STAPH INFECTION. REPORTEDLY, TWO WEEKS AFTER IMPLANT, THE DRAINAGE HAD BEEN NOTICED. THE HEALTH CARE PROVIDER (HCP) HAD UPPED THE PATIENT¿S DOSE 2 TO 3 TIMES TO GET IDEAL THERAPY. THE MOST RECENT UPDATE HAD BEEN ON 2014-09-03. SEVEN TO TEN DAYS AFTER THE PATIENT¿S LAST ANTIBIOTICS, THE PUMP SITE HAD STARTED RUNNING AGAIN. IT WAS NOTED THE HCP ¿ALWAYS PUTS "BANKOMIACIN" ON PUMP SITE TO STAVE INFECTION¿. THE PUMP WAS AS A RESULT OF THE EVENT REMOVED. THE PATIENT WAS CONSIDERING TRYING TO IMPLANT AGAIN SINCE THE PUMP THERAPY HAD WORKED WELL. THE PATIENT¿S HCP HAD SAID THE PATIENT WOULD NEED 6 WEEKS OF ORAL ¿DOCLACYCLIN¿ ANTIBIOTIC THEN THEY WOULD TRY IMPLANTING ON THE OTHER SIDE. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION INCLUDING THE CAUSE OF THE EVENT, DIAGNOSTICS AND FINAL PATIENT OUTCOME HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD DEVELOPED A STAPH INFECTION. REPORTEDLY, TWO WEEKS AFTER IMPLANT, THE DRAINAGE HAD BEEN NOTICED. SEVEN TO TEN DAYS AFTER THE PATIENT'S LAST ANTIBIOTICS, THE PUMP SITE HAD STARTED RUNNING AGAIN. IT WAS NOTED THE HEALTH CARE PROVIDER (HCP) "ALWAYS PUTS BANKOMIACIN ON PUMP SITE TO STAVE INFECTION". THE PUMP WAS AS A RESULT OF THE EVENT REMOVED. THE PATIENT WAS CONSIDERING TRYING TO IMPLANT AGAIN SINCE THE PUMP THERAPY HAD WORKED WELL. THE PATIENT'S HCP HAD SAID THE PATIENT WOULD NEED 6 WEEKS OF ORAL "DOCLACYCLIN" ANTIBIOTIC THEN THEY WOULD TRY IMPLANTING ON THE OTHER SIDE. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION INCLUDING THE CAUSE OF THE EVENT, DIAGNOSTICS AND FINAL PATIENT OUTCOME HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639112 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention