Device Recall Medtronic InSync III Protect

  • Model / Serial
    Model 7285 InSync III Protect (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: PPC800001Q - PP800011Q. H-Series: PPC100002H - PPC100005H. S-Series: PPC600001S - PPC600184S.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    worldwide
  • Product Description
    Medtronic InSync III Protect, model 7285 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy 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