BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3181930 · Received June 21, 2013

    Report

    Report Number
    3007566237-2013-02052
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    April 5, 2013
    Report Date
    May 29, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO ANOMALIES. ALTHOUGH SOME RESIDUE WAS FOUND THROUGHOUT THE INSIDE OF THE PUMP THE DEVICE PERFORMED PER SPECIFICATIONS. RETURNED FOR ANALYSIS WAS ALSO THE CATHETER; THE 8578 SC CONNECTOR HAD CORING-TEARS-CUTS IN SEAL, WHILE THE 8709 CATHETER SEGMENT HAD A DARK RESIDUE IN DISPENSING HOLES, HOWEVER THEY WERE ANALYZED TO BE PATENT AS RECEIVED WITH NO LEAKING DURING TESTING.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: ACCESSORY: PRODUCT ID 8709, LOT# L58359, IMPLANTED: (B)(6) 1999, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER: PRODUCT ID 8835, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    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 THE PATIENT EXPERIENCED WITHDRAWAL WITH UNDERDOSE SYMPTOMS AND THEN HAD OVERDOSE SYMPTOMS. A CATHETER ACCESS PORT STUDY WAS PERFORMED AND SHOWED NORMAL CATHETER FLOW. THERE WAS A NOTED VOLUME DISCREPANCY WHERE THE EXPECTED VOLUME WAS 19.1ML, BUT THE RESERVOIR ONLY CONTAINED 15ML. THE HEALTHCARE PROFESSIONAL OPTED TO REPLACE THE PUMP AND CATHETER SYSTEM ON THE DAY OF REPORT. THE DEVICE SYSTEM HAD BEEN USED TO DELIVER DILAUDID AND MARCAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282093 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Other| R