BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2920782 · Received January 17, 2013

    Report

    Report Number
    3007566237-2013-00226
    Event Type
    Injury
    Date Received
    January 17, 2013
    Report Date
    December 26, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CATHETER: MODEL 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: UNK. (B)(4). ST SEGMENT ELEVATION. SPINAL DISC CONTUSIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERMITTENT WITHDRAWAL OCCURRED. THE PATIENT EXPERIENCED "INTERMITTENT" WITHDRAWAL, "SUGGESTING" INTERMITTENT OCCLUSION PROBLEMS. SYMPTOMS ASSOCIATED WERE INCREASED PAIN, HYPOTENSIVE REBOUND, AGITATION AND ST SEGMENT ELEVATION. INTERVENTIONS INCLUDED DOSE ADJUSTMENTS BETWEEN (B)(6) 2012 AND (B)(6) 2012, "RESULTING IN INTENSITY OF WITHDRAWAL EPISODES DIMINISHED WITH PROGRESSIVE LOWERING OF DOSE, BUT INCREASED CLINICAL PAIN." A CATHETER DYE STUDY WAS DONE (B)(6) 2012 WITH "NORMAL, PATENT" RESULTS. IT WAS ALSO NOTED THAT AN MRI/XRAY/CT SCAN WAS DONE, NO RESULTS, NO DATE WAS REPORTED. HOSPITALIZATION WAS REQUIRED. A CATHETER REVISION WAS DONE, IT WAS REPORTED "NO CATHETER SLUDGE IDENTIFIED," "NO OBVIOUS CATHETER ENCAPSULATION," THE ORIGINAL CATHETER WAS "NEVER" SUTURED. THE HCP NOTED EXCESSIVE CATHETER LENGTH TUCKED INTO PUMP POCKET AND "FELT" IT TO BE LIABLE FOR INTERMITTENT EXTERNAL MECHANICAL OBSTRUCTION (KINKING.) IT WAS ALSO NOTED "SPINAL DISC CONTUSIONS HAVE BEEN REDUCED," IT IS UNCLEAR IF THIS IS RELATED TO THE EVENT OR NOT. PATIENT OUTCOME AT THE TIME OF THIS REPORT WAS NON-SERIOUS INJURY/ILLNESS. THE DEVICE SYSTEM WAS USED TO INFUSE FENTANYL, BUPIVACAINE, AND CLONIDINE. IT WAS LATER REPORTED THAT THE PATIENT WAS DOING "FINE" SINCE THE REPLACEMENT, THESE SYMPTOMS HAD RESOLVED AND THE CAUSE OF THE EPISODES WAS A KINKED CATHETER. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26538 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention