BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3211700 · Received July 8, 2013

    Report

    Report Number
    3004209178-2013-11464
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 9, 2013
    Report Date
    June 14, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-3043-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER; PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE PUMP FOUND A PUMP MOTOR FEED THRU ANOMALY; SHORTING ACROSS THE INSULATOR.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CRITICAL ALARM WAS HEARD AND CONFIRMED BY TELEMETRY. THE PUMP LOGS INDICATED THAT ¿RESET OCCURRED-LOW BATTERY¿ OCCURRED ON (B)(6) 2013. IT WAS ALSO REPORTED THAT THE LOGS STATED THAT THE PUMP WAS IN SAFE STATE AND A MOTOR STALL OCCURRED. THE PATIENT PREVIOUSLY HAD MULTIPLE MOTOR STALLS AND RECOVERIES. AT THE TIME OF THE REPORT, THE PUMP WAS GOING TO BE PUT IN MINIMUM RATE MODE. THE DEVICE SYSTEM WAS USED TO DELIVER HYDROMORPHONE. IT WAS LATER REPORTED THAT THE PATIENT WAS SCHEDULED TO HAVE HER PUMP REPLACED. THE PATIENT EXPERIENCED RETURN OF PAIN. THE HEALTHCARE PROVIDER (HCP) WAS TO MANAGE THE PATIENT WITH ORAL MEDICATION UNTIL THE PUMP WAS REPLACED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT WAS DOING FINE AND GETTING GOOD THERAPY. IT WAS SAID IT WAS UNKNOWN WHY THE CATHETER COULD NOT BE ASPIRATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PUMP WAS REPLACED ON (B)(6) 2013 DUE TO WHAT WAS BELIEVED TO BE A "FEED THROUGH SHORT". IT WAS LATER REPORTED THAT DURING THE PUMP REPLACEMENT THE HEALTH CARE PROVIDER (HCP) WAS UNABLE TO ASPIRATE THE CATHETER. IT WAS LATER REPORTED THAT THE PATIENT WAS KEPT IN THE HOSPITAL OVERNIGHT FOR OBSERVATION FOLLOWING THE PUMP REPLACEMENT, AND WAS DOING WELL. IT WAS LATER REPORTED THAT THERE WAS NO DIAGNOSTICS OR TROUBLESHOOTING PERFORMED WITH THE PUMP REGARDING THE MOTOR STALLS AND SUBSEQUENT REPLACEMENT. THERE WAS NO PATIENT INJURY, AND THE PATIENT OUTCOME WAS RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308625 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R