Device Recall Medtronic Maximo DR

  • Model / Serial
    Model 7278 Maximo DR (serial numbers listed include all affected devices but may include some unaffected devices. Patients are recommended to check with their doctor for exact serial numbers affected.) Q-Series: PRM800001Q - PRM800123Q. S-Series: PRM600001S - PRM605919S and PRM606025S - PRM606035S
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    worldwide
  • Product Description
    Medtronic Maximo DR, model 7278 Single Chamber Implantable Cardioverter Defibrillator (ICD)devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventricular arrhythmias and delivery of user-selected therapies for the detected arrhythmia. Therapies are automatically delivered following detection or can be initiated via programming by the physician. These ICDs are multi-programmable and have the capability of transmitting via telemetry the programmed values, measured and collected data, and event markers.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Medtronic Inc. Cardiac Rhythm Managment, 7000 Central Ave Ne, Fridley MN 55432
  • Source
    USFDA