BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5131414 · Received October 7, 2015

    Report

    Report Number
    3004209178-2015-20110
    Event Type
    Injury
    Date Received
    October 7, 2015
    Date of Event
    September 3, 2015
    Report Date
    September 11, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8711, SERIAL # (B)(4), EXPLANTED: (B)(6) 2015, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP). THE PATIENT'S UNDERLYING DISEASE WAS HEREDITARY SPASTIC PARAPLEGIA WITH A DATE OF DIAGNOSIS IN YEAR 1993 (SPECIFIC DATE NOT KNOWN TO REPORTER). THE PATIENT'S COMPLICATIONS/PAST HISTORY INCLUDED: NEUROGENIC BLADDER WITH DATE OF ONSET (B)(6) 2013; INSOMNIA WITH DATE OF ONSET (B)(6) 2009 FOR WHICH THE PATIENT TOOK THE DRUG MYSLEE (5) TABLET; PROSTATOMEGALY WITH DISEASE DURATION (B)(6) 2013 THROUGH (B)(6) 2014. REGARDING THE PUMP INFECTION, THE PATIENT'S OUTCOME FOLLOWING PUMP AND CATHETER EXPLANT SURGERY WAS REPORTED AS RECOVERED AS OF (B)(6) 2015 AND THE PATIENT WAS DISCHARGED AND WENT BACK HOME. REGARDING THE CAUSAL RELATIONSHIP OF THE ADVERSE EVENT TO THE DRUG GABALON, YES AS REPORTED. THE PATIENT EXPERIENCED NO OVERDOSE OR WITHDRAWAL SYMPTOMS. FOLLOWING THE PUMP REPLACEMENT SURGERY ON (B)(6) 2015, THE PATIENT WAS DISCHARGED AND WENT BACK HOME ON (B)(6) 2015. PHYSICIAN NOTES REPORTED THERE WAS "TICK FILM/MEMBRANE TISSUES" COVERING AROUND THE PUMP AND POOR BLOOD FLOW AT THE PUMP SYSTEM REPLACEMENT PROCEDURE. THE SITE WAS CLEANED WITH SALINE INCLUDING ANTIBIOTICS MULTIPLE TIMES TO AVOID INFECTION. ANTIBIOTICS WERE ADMINISTRATED FOR FIVE DAYS AFTER THE PROCEDURE, BUT THE PATIENT EXPERIENCED INFECTION IN THE END. ADDITI ONAL INFORMATION REPORTED THE PATIENT HAD A FEVER OF 38.3 DEGREES CELSIUS ON (B)(6) 2015. ON (B)(6) 2015, ANTIBIOTICS WERE ADMINISTERED CONTINUOUSLY AND (B)(6) WAS POSITIVE IN THE BOWELS. THE EVENT HAD A CAUSAL RELATIONSHIP WITH THE PUMP AND CATHETER. INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER WHO INDICATED THAT IN RELATION TO THE INFECTION, THE DRUG HAD BEEN DISCONTINUED AND THE PUMP AND CATHETER WERE REMOVED AS AN INTERVENTION. THE PATIENT RECEIVED GABALON INTRATHECAL (0.05%) AT A DOSE RATE OF 65 MCG/DAY FROM (B)(6) 2015 TO (B)(6) 2015 (THE INITIAL DOSE AT IMPLANT WAS 69.9 MCG/DAY). THE PATIENT ALSO RECEIVED MEROPENEM DRIP INFUSION OF 0.5G VIA IV OF 1 GRAM THREE TIMES DAILY FROM (B)(6) 2015 TO (B)(6) 2015. LABORATORY TESTS WERE PERFORMED ON (B)(6) 2015 THAT INDICATED THE PATIENT HAD AN INCREASE IN WHITE BLOOD CELLS (LOWER/UPPER RANGE WAS 3300/8600 CELLS/UL). THE WHITE BLOOD CELL COUNTS WERE: 9900, 10100, 3980, AND 4200. THE C-REACTIVE PROTEIN LEVEL WAS ALSO INCREASED (NORMAL RANGE 0.00/0.14 MG/DL). THE C-REACTIVE PROTEIN COUNTS WERE 6.09, 15.49, 4.65, AND 0.13. THE PATIENT HAD NO CONCOMITANT WORK OR PHYSICAL THERAPY. ON (B)(6) 2015, THE PATIENT CONSULTED THE PHYSICIAN DUE TO A FEVER, AND SWELLING AND A RASH AT THE PUMP SITE. IT WAS ON (B)(6) 2015 THAT THE PUMP IMPLANT SITE INFECTION WAS DETERMINED, THE EXPLANT SURGERY OF THE PUMP/CATHETER WAS PERFORMED AND THE ADMINISTRATION OF THE ANTIBIOTICS WERE CONTINUED. IT WAS FURTHER CLARIFIED THAT DURING THE REPLACEMENT, THE PUMP WAS COVERED WITH A COATING-LIKE STRUCTURE WITH AN IMPRESSION OF POOR BLOOD CIRCULATION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER IN REGARDS TO A PATIENT WHO WAS BEING TREATED WITH GABALON INTRATHECAL FOR SPINO CEREBELLAR DEGENERATION. THE PATIENT¿S PUMP WAS IMPLANTED ON (B)(6) 2015 AND THE DOSING PERIOD WAS 70-50 MCG/DAY FROM (B)(6) 2009 THROUGH (B)(6) 2015. THE PATIENT EXPERIENCED AN INFECTION IN THE BUTTOCKS ON (B)(6) 2015, WAS CONSIDERED SERIOUS, AND REQUIRED HOSPITALIZATION. THE EVENT WAS UNRECOVERED. THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE EVENT AND THE CATHETER, DRUG, PUMP, OR PROGRAMMER. IT WAS UNKNOWN IF THERE WAS A CAUSAL RELATIONSHIP WITH THE SURGICAL PROCEDURE. ON (B)(6) 2015, A PUMP REPLACEMENT PROCEDURE WAS PERFORMED. AT THE END OF (B)(6) 2015, THE PATIENT WAS FINE AND DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2015, AFTER DISCHARGE, THE PATIENT COMPLAINED THAT THE IMPLANT POCKET SITE WAS SWELLING AND THERE WAS REDNESS, WHICH WAS AN UNUSUAL CONDITION. AS A RESULT, THE PATIENT VISITED THE HOSPITAL. ALTHOUGH THE PATIENT HAD NO SYMPTOMS OF THE EVENT, THE PHYSICIAN SUSPECTED THAT THIS EVENT WAS AN INFECTION. ON (B)(6) 2015, THE PUMP SYSTEM WAS EXPLANTED DUE TO INFECTION. AT THE PUMP EXPLANT PROCEDURE, PUS WAS CONFIRMED IN THE PUMP POCKET SITE. ON (B)(6) 2015, THE PATIENT WAS TAKING LIORESAL, 8 TABLETS PRESENTLY. PER THE ATTENDING PHYSICIAN¿S ASSESSMENT, THE INFECTION IN THE PUMP IMPLANT SITE WAS SUSPECTED WHEN THE PATIENT VISITED THE HOSPITAL. THE PUMP SYSTEM WAS IMMEDIATELY EXPLANTED, AND THE INFECTION DID NOT SEEM TO EXPAND IN THE PATIENT¿S BACK. ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) INDICATED THE PATIENT¿S PUMP WAS IMPLANTED ON (B)(6) 2015 (PREVIOUSLY REPORTED (B)(6) 2015) AND WAS EXPLANTED ON (B)(6) 2015. THE PATIENT¿S DAILY DOSE WAS "70-60 MCG" AND THE DOSING PERIOD WAS FROM (B)(6) 2009 THROUGH (B)(6) 2015. THE EVENT WAS UNRELATED TO THE INVESTIGATIONAL DRUG. AS OF (B)(6) 2015, THE PATIENT WAS NOT RECOVERED. A PUMP OPERABILITY TEST, ROTOR TEST, AND CATHETER X-RAY WERE NOT PERFORMED. ON (B)(6) 2015, THE PUMP WAS REPLACED AND IN LATE AUGUST THE PATIENT RECOVERED AND WAS DISCHARGED. ON (B)(6) 2015, AFTERWARDS, THE PUMP IMPLANTATION REGION TURNED RED AND BECAME SWOLLEN. THE PATIENT SAID IT FELT STRANGE SO HE WENT TO THE HOSPITAL TO HAVE IT CHECKED. THERE WERE NO SUBJECTIVE SYMPTOMS IN PARTICULAR, BUT THE HEAD PHYSICIAN LOOKED AT IT AND SUSPECTED AN INFECTION. THE PUMP SYSTEM WAS REMOVED DUE TO INFECTION. AT THAT TIME, ¿X¿ WAS CONFIRMED FROM THE PUMP POCKET. THE PATIENT WAS CURRENTLY TAKING 6 LIORESAL TABLETS. IT WAS FURTHER REPORTED AN INFECTION IN THE PUMP IMPLANTATION AREA WAS SUSPECTED WHEN THE PATIENT VISITED THE HOSPITAL, SO THE PUMP WAS REMOVED IMMEDIATELY. IT SEEMED LIKE THE INFECTION HAD NOT MIGRATED TO THE BACK REGION. ADDITIONAL INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) CLARIFIED THE PATIENT¿S DAILY DOSE WAS ¿70-50¿ MCG/DAY. IN LATE AUGUST, THE PATIENT WAS DISCHARGED IN GOOD SPIRITS. IT WAS ALSO CLARIFIED ¿PUS¿ WAS OBSERVED COMING FROM THE PUMP POCKET. ON (B)(6) 2015, ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP). PHYSICIAN NOTES REPORTED THERE WAS "TICK FILM/MEMBRANE TISSUES" COVERING AROUND THE PUMP AND POOR BLOOD FLOW AT THE PUMP SYSTEM REPLACEMENT PROCEDURE. THE SITE WAS CLEANED WITH SALINE INCLUDING ANTIBIOTICS MULTIPLE TIMES TO AVOID INFECTION. ANTIBIOTICS WERE ADMINISTRATED FOR FIVE DAYS AFTER THE PROCEDURE, BUT THE PATIENT EXPERIENCED INFECTION IN THE END. ADDITIONAL INFORMATION REPORTED THE PATIENT HAD A FEVER OF 38.3 DEGREES CELSIUS ON (B)(6) 2015. ON (B)(6) 2015, ANTIBIOTICS WERE ADMINISTERED CONTINUOUSLY AND (B)(6) WAS (B)(6) IN THE BOWELS. IT WAS REPORTED THAT THE PATIENT RECOVERED FROM THE ADVERSE EVENT ON (B)(6) 2015. THE EVENT HAD A CAUSAL RELATIONSHIP WITH THE PUMP AND CATHETER.

    Description of Event or Problem · 1

    ON 2015-10-30, ADDITIONAL INFORMATION WAS RECEIVED FROM AN HEALTHCARE PROFESSIONAL (HCP). IT WAS REPORTED THAT THE CAUSAL RELATIONSHIP WITH THE INVESTIGATIONAL DRUG (BACLOFEN INFUSION) AND "PUMP INFECTION", WAS MODIFIED TO "NOT RELATED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662130 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| O| R