Events

Recall of Viva ICD

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Inc., Cardiac Rhythm and Heart Failure.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74923
  • Event Risk Class
    Class 2
  • Event Number
    Z-2650-2016
  • Event Initiated Date
    2016-08-12
  • Event Date Posted
    2016-08-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148794
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
  • Reason
    78 viva crt -ds and evera icds that were manufactured with a specific subset of circuit components may experience rapid battery depletion due to a low resistance path developing within the circuit component. there have been seven (7) confirmed failures (9%) through july 16, 2016. reported complications have included shortness of breath, pocket heating, low heart rate, and early device explant.
  • Action
    Consignees were sent or hand delivered on August 12, 2016 a Medtronic "Urgent Medical Device Correction" letter dated August 2016. The letter was addressed to Physician. The letter described the problem and the devices involved in the recall. The letter described a number of "Patient Management Recommendations". For questions contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636.

Device

Viva ICD
  • Model / Serial
    Product Name: Viva XT CRT -D . Models: DTBA1D4, DTBA1D1. Serial Numbers:  BLF203128H, BLF204746H, BLE202888H, BLE202889H, BLE202890H, BLE202901H, BLE202941H, BLE202947H, BLE202954H, BLE202958H, BLE202961H, BLE202962H, BLE202964H, BLE202981H, BLE202987H, BLE202989H, BLE202990H, BLE202991H, BLE203019H, BLE203026H, BLE203027H, BLE203029H, BLE203032H, BLE203046H, BLE203052H, BLE203073H  Product Name: Viva S CRT-D. Models: DTBB1D4, DTBB1D1. Serial Numbers: BLO202272H, BLN202206H.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide in the states of US: AZ, CA, FL, GA, IL, KY, MD, MN, NJ, NY, NC, OH, OK, PA, PR, TX. and countries of: Australia, Finland, France, Germany, Iran, Italy, Japan, Korea, Netherlands, Puerto Rico, Saudi Arabia, Spain, and United Kingdom.
  • Product Description
    Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: || Product Model || VIVAXTCRT-D DTBA1D1, DTBA1D4 || VIVASCRT-D DTBB1D1, DTBB1D4 || Product Usage: || The Medtronic Viva CRT -D dual chamber, implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT -D) is a multiprogrammable cardiac device that monitors and regulates the patients heart rate by providing single or dual chamber, rate responsive bradycardia pacing; sequential biventricular pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies.
  • Manufacturer
    Medtronic Inc., Cardiac Rhythm and Heart Failure

Manufacturer

Medtronic Inc., Cardiac Rhythm and Heart Failure
  • Manufacturer Address
    Medtronic Inc., Cardiac Rhythm and Heart Failure, 8200 Coral Sea St NE, Mounds View MN 55112-4391
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • 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
    USFDA