BEUDAMED
    FDA Recall Terminated

    Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device is typically connected to temporary transvenous, epicardial or myocardial pacing leads, in a bipolar configuration, using a patient cable (Medtronic Model 5433A or 5433V) or a surgical cable (Medtronic Model 5832 or 5832S).

    Recall: Z-1661-2014 · Initiated April 29, 2014

    Recall

    Recall Number
    Z-1661-2014
    Event Number
    68165
    Firm
    Medtronic Inc. Cardiac Rhythm Disease Management
    FEI Number
    2182208
    Product Code
    LWP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 29, 2014
    Posted
    May 24, 2014
    Terminated
    October 8, 2014
    Address
    8200 Coral Sea St NE, Saint Paul, MN, 55112-4391

    Description

    Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Generator (EPG) Temporary Pacemaker (AAI/VVI). Used in conjunction with a cardiac pacing lead system for temporary atrial or ventricular pacing in a clinical environment. The device is typically connected to temporary transvenous, epicardial or myocardial pacing leads, in a bipolar configuration, using a patient cable (Medtronic Model 5433A or 5433V) or a surgical cable (Medtronic Model 5832 or 5832S).

    Reason

    Events related to a pacing rate outside of the intended setting, including events of sudden increased pacing rate up to the maximum setting of 180 pulses per minute (ppm), have been reported. This is caused by the development of high resistance on internal electrical connector contacts due to oxidation over time.

    Action

    Consignees were sent a Medtronic "Urgent Medical Device Correction" letter dated April 2014. The letter was addressed to Risk Manger, Health Care Professional. The letter included the Issue Description, Root Cause, Potentially Affected 5348 EPGs within the Serial Number Ranges, Malfunction Indications, and Recommended Actions. For questions related to EPG service policy or purchasing a replacement EPG, customers should contact your Medtronic representative. For technical questions, please call Instruments Technical Service at (1-800)638-1991. Medtronic asks that customers complete and sign the attached Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality or e-mail to [email protected].

    Distribution

    Worldwide Distribution -- USA, including the territories of Guam and Puerto Rico; and, the countries of Albania, Algeria, Australia, Austria, Bahamas, Bangladesh, Belarus, Belgium, Benin, Bolivia, Bosnia And Herzegovina, Brazil, Bulgaria, Burkina Faso, Chile, Colombia, Costa Rica, Cote D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, Georgia, Germany, Greece, Guadeloupe, Honduras, Hong Kong, Hungary, India, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Morocco, Nepal, Netherlands, Netherlands Antilles, New Caledonia, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Yemen.

    Quantity

    16,337 (8,989 US; 7,348 OUS)