BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2230765 · Received August 23, 2011

    Report

    Report Number
    3007566237-2011-06712
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 23, 2011
    Report Date
    July 29, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CRITICAL ALARM DUE TO MOTOR STALL, CONFIRMED BY (B)(6) WAS REPORTED. PATIENT WAS FEELING INCREASED PAIN. ELECTROMAGNETIC INTERFERENCE WAS RULED OUT CAUSING THE STALL. IT WAS LATER REPORTED THAT THE PUMP HAD STALLED FOR (B)(6), PER TELEMETRY STRIPS THE DATE OF STALL WAS (B)(6) 2011. IT WAS STATED, "A SUDDEN PUMP STOPPAGE", CAUSE UNKNOWN. PATIENT WENT THROUGH OPIOID WITHDRAWAL. THE DRUGS DELIVERED VIA THE PUMP WERE HYDROMORPHONE, BUPIVACAINE AND CLONIDINE. THE DEVICE WAS REPLACED. THERE WAS NO INJURY AND THE PATIENT WAS NOT HOSPITALIZED BECAUSE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention IMPLANTED:| CATHETER: MODEL 8731, LOT# N002579334| EXPLANTED: