BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2874839 · Received December 16, 2012

    Report

    Report Number
    3007566237-2012-03029
    Event Type
    Malfunction
    Date Received
    December 16, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 16, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: CATHETER MODEL: 8703W, LOT#: L36315, IMPLANTED: (B)(6) 1995, EXPLANTED: UNK. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PUMP REPLACEMENT SURGERY ON (B)(6) 2012 A CATHETER BREAK WAS OBSERVED AND NEEDED TO BE REPLACED. PATIENT WAS UNABLE TO FEEL THE NEW CATHETER AND INDICATED THAT HE WAS VERY LEAN AND WAS TO FOLLOW-UP WITH THE HEALTHCARE PROVIDER ON (B)(6) 2012. NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT WERE REPORTED. DRUG DELIVERED VIA THE DEVICE WAS MORPHINE. ON (B)(6) 2012 IT WAS REPORTED THAT PATIENT HAD NO CONCERNS REGARDING DEVICE OR THERAPY AND THAT HE RECEIVED ASSISTANCE AND HIS CONCERNS WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR