BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESTREAM INTRASPINAL CATHETER KIT

    MDR report key: 3162811 · Received June 11, 2013

    Report

    Report Number
    1226348-2013-18591
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 19, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    LMP
    PMA / PMN Number
    PP890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THE CATHETER WAS VISUALLY EVALUATED. THERE WAS NO EVIDENCE OF CUTS, TEARS OR HOLES ON THE SILICONE MATERIAL. ADDITIONALLY, THERE WAS NO EVIDENCE, DEBRIS, DISCOLORATION OR FOREIGN MATTER ON THE SURFACE OF THE CATHETER MATERIAL. THE ORIGINAL SILICONE PUMP CATHETER WAS ATTACHED TO A SURESTREAM CATHETER (WITH A CONNECTOR). BOTH CATHETERS WERE SECURE AND COULD BE FLUSHED WITH NO RESISTANCE. LEAKAGE WAS NOT FOUND WHEN FLUSHING CATHETER AND BOTH CATHETERS WERE PATENT, LEAK TIGHT AND ANOMALY FREE. THE REPORTED "CATHETER MIGRATED FROM THE INTRASPINAL LOCATION" IS NOT BELIEVED TO BE ASSOCIATED WITH CATHETER MALFUNCTION. ADDITIONALLY, IT WAS REPORTED THAT "PATIENT WAS BEING TREATED FOR AN INFECTION"; HOWEVER, THE CLINICIAN ADVISED "AT THIS TIME IT IS BELIEVED THAT THE INTRASPINAL CATHETER IS NOT ASSOCIATED TO THE PATIENT'S INFECTION". THE CATHETER ISSUES EXPERIENCED IN THE CLINICAL SETTING WERE MOST LIKELY DUE TO CATHETER PLACEMENT AND PATIENT CONDITION AND ARE NOT ATTRIBUTED TO CATHETER MALFUNCTION. THE LOT NUMBER WAS NOT REPORTED; THEREFORE IT IS NOT POSSIBLE TO REVIEW THE DEVICE HISTORY RECORDS FOR THE SUBJECT CATHETER. BASED ON THIS EVALUATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT THE PATIENT WAS ADMITTED WITH SPASTICITY. THE ER VERIFIED THAT THE CATHETER MIGRATED FROM THE INTRASPINAL LOCATION TO THE PUMP POCKET. DUE TO THE PATIENT BEING TREATED FOR AN INFECTION, THE ENTIRE SYSTEM INCLUDING THE MEDSTREAM PUMP WAS EXPLANTED. AT THIS TIME, IT IS NOT BELIEVED THAT THE CATHETER WAS ASSOCIATED WITH THE PATIENT¿S INFECTION. THE SYSTEM WILL BE RETURNED FOR AN EVALUATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THAT THE SALES REP WAS INSTRUCTED TO STOP THE PUMP FLOW. WHEN THE REP TRIED TO REPROGRAM THE DEVICE, HE RECEIVED A LOW BATTERY ALARM. THE BATTERY ISSUE WAS NOT A FACTOR WHEN THE INFECTION WAS DETECTED. THE PUMP WAS NEVER SHUT OFF AFTER THE EXPLANT. AFTER RE-INTERROGATION OF THE PUMP, IT WAS CONFIRMED THAT THE PUMP WAS STOPPED BUT THE REP STILL RECEIVED THAT BATTERY WARNING MESSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262383 SURESTREAM INTRASPINAL CATHETER KIT PORT & CATH, IMPLANTED, SUBCUT INTRASPINAL LMP CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention