BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3082638 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-07013
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 1, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8731, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE CATHETER. (B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE PUMP REVEALED PUMP MOTOR FEEDTHRU ANOMALY, SHORTING ACROSS INSULATOR.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PUMP REPLACEMENT WAS DUE TO NORMAL BATTERY DEPLETION. IN REGARDS TO THE CONNECTOR, IT WAS ADDED THAT IT HAD "WORN OUT" AT THE PUMP/CATHETER CONNECTION SITE - REPORTED "BAD" PREVIOUSLY AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S PUMP EXPERIENCED BATTERY DEPLETION, PUMPING STOPPED, AND AT A SUBSEQUENT REPLACEMENT, THE HEALTHCARE PROVIDER (HCP) ENCOUNTERED CATHETER ISSUES. DURING THE PUMP REPLACEMENT ON THE DAY OF REPORT, A CATHETER PUMP CONNECTOR WAS FOUND TO BE "BAD." IT WAS NOTED THAT THE CONNECTOR WAS BAD BUT THE CATHETER WAS "WORKING GREAT." THE REPORTER WAS UNABLE TO PROVIDE ANY FURTHER DETAILS AT THAT TIME, AS THEY WERE IN THE PROCESS OF REVISING. IT WAS LATER REPORTED THAT THE PUMP WAS BEING REPLACED FOR BATTERY DEPLETION, AND THE CATHETER ISSUE WAS FIXED WITHIN THE PUMP REVISION. THE PUMP DEVICE WAS LATER RETURNED, AT WHICH TIME THE REPORTER DESCRIBED REASON FOR REPLACEMENT OF THE PUMP, AS A MOTOR STALL AND A STOPPED PUMP. THE EVENT WAS NOTED TO BE DEVICE RELATED, BUT THE REASON FOR THE MOTOR STALL AND STOPPED PUMP NOT KNOWN, AS THE ESTIMATED REPLACEMENT INDICATOR (ERI) HAD 15 MONTHS REMAINING. THE PATIENT OUTCOME WAS NOTED AS RECOVERED WITHOUT SEQUELAE. PER THE DEVICE LOGS UPON DEVICE RETURN, THE PUMP WAS USED TO DELIVER FENTANYL, BACLOFEN AND BUPIVACAINE. IT WAS LATER REPORTED IN REGARDS TO THE MOTOR STALL, REPORTER NOTED IT DID RECOVER BUT NOT WITHIN 2 HOURS. NO TIMEFRAME DETAILS WERE RECEIVED. THE PATIENT EXPERIENCED A "SLIGHT RETURN OF PAIN." THE REPORTER HAD NO FURTHER UPDATE ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183737 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention