BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3192357 · Received June 27, 2013

    Report

    Report Number
    3004209178-2013-10953
    Event Type
    Injury
    Date Received
    June 27, 2013
    Report Date
    May 31, 2013
    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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: 2013, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8709 LOT# L69914, IMPLANTED: 2000 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INITIAL ANALYSIS RESULT OF THE CATHETER, SERIAL NUMBER (B)(4), WAS CODED RELIABILITY NON-CONFORMANCE. THIS TEAR IN THE SILICONE SEAL ISSUE WAS FURTHER INVESTIGATED INTERNALLY AND CONCLUDED THAT THE CORRECT CODING SHOULD BE NO SIGNIFICANT ANOMALY AND/OR EXPLANT DAMAGE. ANALYSIS OF DEVICES WITH OBSERVED TEARS IN THE SEAL NEAR THE GUIDE RING DETERMINED THAT THE ANOMALY DOES NOT AFFECT DEVICE PERFORMANCE OR ITS ABILITY TO MEET PRODUCT SPECIFICATIONS. THE TEARS IN THE SEAL MATERIAL DO NOT AFFECT THE CONNECTOR PERFORMANCE AND THEY DO NOT PREVENT THE CONNECTION FROM REMAINING PATENT OR CREATE A LEAK CONDITION. IN ADDITION, THERE ARE NO ALLEGATIONS OF EMBOLISMS DUE TO TEAR. THESE TEARS IN THE SEAL ALSO DO NOT PRESENT A PERFORMANCE ISSUE TO THE CONNECTOR IF THE CATHETER IS RECONNECTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID; 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4). ANALYSIS OF THE PUMP REVEALED THAT, UNRELATED TO THE REASON FOR THE PUMP¿S RETURN, THE PUMP SUFFERED A PRESCRIPTION TABLE CORRUPTION THAT CAUSED THE PUMP TO RESET INTO SAFE MODE WHILE SITTING UNDISTURBED IN THE LAB IN A BODY TEMPERATURE OVEN. ANALYSIS DID NOT FIND ANYTHING WRONG WITH THE HYBRID AND DESTRUCTIVE ANALYSIS FOUND NO OTHER ANOMALIES WITH THE PUMP. THE HYBRID WAS FULLY FUNCTIONAL, AND THE CAUSE OF THE REPORTED FAILURE WAS NOT DETERMINED. THE CATHETER WAS RETURNED IN FOUR PIECES. ANALYSIS OF THE CATHETER ((B)(4)) REVEALED A TEAR IN THE SEAL OF THE SUTURELESS CONNECTOR NEAR THE GUIDE RING. ANALYSIS OF THE CATHETER (L69914) REVEALED A USER RELATED HOLE IN THE CATHETER BODY.

    Description of Event or Problem · 1

    A REPRESENTATIVE LATER REPORTED THE PATIENT PRESENTED TO THE HOSPITAL ON (B)(6) 2013 WITH AN INFECTION. THE WOUND DEHISCED AND THE PUMP HAD BECOME CONTAMINATED. THE PATIENT WAS ON AN AGGRESSIVE STEP DOWN OF 100 MCG/ML PER DAY UNTIL THE PUMP COULD BE EXPLANTED. THE PATIENT WAS TO BE UNDER HOSPITAL CARE UNTIL IT WAS RESOLVED. A REPRESENTATIVE LATER REPORTED THE PATIENT¿S PUMP WAS EXPLANTED ON (B)(6) 2013 AS MINIMUM RATE WAS ENABLED THE DAY PRIOR TO THE REPORT. THE PATIENT HAD A WEEK LONG AGGRESSIVE STEP DOWN IN BACLOFEN OF APPROXIMATELY 100 MCG/DAY UNTIL MINIMUM RATE WAS ACHIEVED. THE PUMP POCKET HAD BECOME INFECTED AND WAS ERODING THROUGH.

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE PATIENT HAD THEIR PUMP AND PROXIMAL CATHETER REPLACED ON (B)(6) 2013. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013. THE PATIENT LEFT THE HOSPITAL ON 6000 MCG/DAY OF BACLOFEN. SINCE THE PATIENT WENT HOME THEY HAVE HAD ¿TERRIBLE SPASTICITY¿. THE PHYSICIAN MET WITH THE PATIENT AND BOLUSED HER 150 MCG WITH NO RESPONSE. THEY INCREASED THE DOSE TO 850 MCG/DAY. THE PATIENT WAS GIVEN ORAL BACLOFEN 40 MG THREE TIMES PER DAY. THEY WERE ALSO PROVIDED PERIACTIN AND VALIUM. THE PATIENT TOOK A DOSE OF ORAL MEDS AND ¿GOT CONFUSED¿ AND RAN THEIR WHEELCHAIR INTO A WALL AND BROKE THEIR FOOT. THE PATIENT WAS NOT ADMITTED TO THE HOSPITAL. THEY WERE AGITATED AND BITING PEOPLE. THE HCP NOTED THAT THEY ¿HOSED HER DOWN¿ WITH ORAL MEDICATIONS OF 40 MG OF BACLOFEN FOUR TIMES PER DAY, AND THEY TRIED TO BOLUS THE PUMP AGAIN WITH NO RESPONSE. THEY INCREASED THE PUMP TO 1000 MCG/DAY, AND THE NURSES WERE INSTRUCTED TO GIVE ORAL BACLOFEN AS NEEDED. THE HCP INDICATED THAT IMAGING AND A CATHETER DYE STUDY WAS DONE AND ¿LOOKED FINE¿. THE MEDICATION USED WITHIN THE SYSTEM WAS LIORESAL. A REPRESENTATIVE LATER REPORTED THAT THE PATIENT HAD WITHDRAWAL SYMPTOMS A FEW DAYS AFTER THEIR SURGERY. THE WITHDRAWAL WAS INTERMITTENT. A DYE STUDY WAS PERFORMED, AND THE NEUROLOGIST BELIEVED THE PATIENT HAD A SMALL CATHETER TEAR TOWARD HER FLANK. THE CATHETER FROM HER FLANK TO HER PUMP WAS REMOVED AND REPLACED. THE PATIENT WAS NOTED TO HAVE REQUIRED HOSPITALIZATION, AND THEIR SYMPTOMS INCLUDED UNDERDOSE SYMPTOMS OF BEING ¿FIDGETY AND MORE SPASTIC¿. ANOTHER HEALTHCARE PROVIDER LATER REPORTED THE MEDICATION USED WITHIN THE SYSTEM WAS COMPOUNDED BACLOFEN. THE PUMP AND CATHETER WERE NOTED TO HAVE BEEN THE CAUSE OF THE EVENT. BOTH A PUMP ¿MALFUNCTION¿ AND A CATHETER ¿LEAK¿ WERE NOTED. THE LOCATION OF THE LEAK WAS UNKNOWN. THE PUMP AND CATHETER WERE REVISED. THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294550 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization| R