BEUDAMED
    FDA Recall Terminated

    Medtronic SynchroMed II Programmable Pump, 8637, Rx Only, Sterilized by ethylene oxide gas, Medtronic inc., Minneapolis, MN 55432-5604. (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Affected products are SynchroMed II Model 8637 pumps with batteries (MECC Lifetest Batteries) manufactured from April 9, 2002 through July 2, 2002 (internally defined as Time Period 1), and from August 15, 2003 to March 16, 2005 (internally defined as Time Period 3). The SvnchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the certain drugs and fluids.

    Recall: Z-2276-2009 · Initiated July 1, 2009

    Recall

    Recall Number
    Z-2276-2009
    Event Number
    52730
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    LKK
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 1, 2009
    Posted
    September 29, 2009
    Terminated
    May 10, 2012
    Address
    7000 Central Ave NE, Minneapolis, MN, 55432-3568

    Description

    Medtronic SynchroMed II Programmable Pump, 8637, Rx Only, Sterilized by ethylene oxide gas, Medtronic inc., Minneapolis, MN 55432-5604. (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Affected products are SynchroMed II Model 8637 pumps with batteries (MECC Lifetest Batteries) manufactured from April 9, 2002 through July 2, 2002 (internally defined as Time Period 1), and from August 15, 2003 to March 16, 2005 (internally defined as Time Period 3). The SvnchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the certain drugs and fluids.

    Reason

    This recall is related to the potential for reduced battery performance in a small percentage of Medtronic Model 8637 SynchroMed II pumps with batteries manufactured during two distinct time periods prior to April 2005. Nature of the Device Issue: As part of ongoing analysis of returned explanted product, Medtronic has confirmed that reduced battery performance resulted in eight (8) occurrence

    Action

    Consignees were sent on July 7, 2009 a Medtronic " Urgent: Medical Device Correction" letter dated July 2009. The letter was addressed to Healthcare Professionals. The letter described the nature of the Device Issue, Scope, Potential Severity of the Issue, Recommendations, Ongoing patient Management Recommendations and Additional Information. Important patient management information is also available at http://www.professional.medtronic.com under the heading Product Advisories. Direct questions to your Medtronic Field Representative or Medtronic Neuromodulation Technical Services by calling at 1-800-707-0933.

    Distribution

    US (including DC and Puerto Rico), Australia, India, canada, Hong Kong, Japan, Austria, Belgium Cyprus, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, San Marino, Saudi Arabi, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom and Vatican City.

    Quantity

    18,572