SPRINT FIDELIS STEROID ELUTING - TRIPOLAR - VENTRICULAR LEAD

  • Model / Serial
    Model Catalog: 6930 (Lot serial: LFK004984V LFK005530V); Model Catalog: 6930 (Lot serial: LFK001689V LFK003047V); Model Catalog: 6930 (Lot serial: LFK001690V LFK004992V); Model Catalog: 6930 (Lot serial: S/N'S LFK004993V LFK004820V); Model Catalog: 6931 (Lot serial: CONTACT); Model Catalog: 6931 (Lot serial: MANUFACTURER); Model Catalog: 6931 (Lot serial: >1000 NUMBERS); Model Catalog: 6949 (Lot serial: MANUFACTURER); Model Catalog: 6949 (Lot serial: >1000 NUMBERS); Model Catalog: 6949 (Lot serial: CONTACT); Model Catalog: 6948 (Lot serial: MANUFACTURER); Model Catalog: 6948 (Lot serial: >100 NUMBERS); Model Catalog: 6948 (Lot serial: CONTACT)
  • Product Description
    SPRINT FIDELIS STEROID ELUTING - TRIPOLAR
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    BRAMPTON
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    HC

One device with a similar name

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  • Model / Serial
    Model Catalog: 6930 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 6949 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 6948 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 6931 (Lot serial: ALL SERIAL NUMBERS)
  • Product Classification
  • Product Description
    SEE 33-02
  • Manufacturer