Device Recall Amplia MRI CRTD, Amplia MRI Quad CRTD

  • Model / Serial
    a. Product No. DTMA1D1: UDI 00643169705777 (Serial No. RPT200245H) (EXPANSION Serial No. RPT201653H, RPT200308H, RPT201033H, RPT202625H, RPT201913H, RPT202623H, RPT202624H, RPT202627H, RPT202626H), 00643169929531 (Serial No. RPT202182H);  b. Product No. DTMA1QQ: UDI 00643169543362 (Serial No. RPA202057H) (EXPANSION: Serial No. RPA200224H, RPA200472H, RPA200673H, RPA201732H, RPA201733H, RPA202258H, RPA202454H, RPA202455H, RPA202649H, RPA202650H, RPA202651H, RPA202652H, RPA202653H, RPA203381H, RPA203416H, RPA203546H, RPA203547H, RPA204428H, RPA204605H, RPA204606H, RPA201333H, RPA202259H), 00643169929562 (Serial No. RPA204495H);   EXPANSION:  c. Product No. DTMA1D4: UDI 00643169543416 (Serial No. RPC200266H, RPC200772H, RPC200830H, RPC201028H, RPC201030H, RPC201382H, RPC201056H, RPC201383H);  d. Product No. DTMA1Q1: UDI 00643169705760 (Serial No. RPS200939H)
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution.
  • Product Description
    Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the following: || a. Claria MRI CRT-D DF1 (Product No. DTMA1D1); || b. Claria MRI Quad CRT-D DF4 (Product No. DTMA1QQ); || EXPANSION: || c. Claria MRI CRT-D DF4 (Product No. DTMA1D4); || d. Claria MRI Quad CRT-D DF1 (Product No. DTMA1Q1) || Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), 8200 Coral Sea St Ne, Mounds View MN 55112-4391
  • 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
    USFDA

One device with a similar name

Learn more about the data here

  • Model / Serial
    a. Product No. DTMB1D4: UDI 00643169543430 (Serial No. RPJ201956H, RPJ202805H) (EXPANSION: Serial No. RPJ201660H, RPJ201661H, RPJ201972H, RPJ202145H, RPJ202821H, RPJ203208H, RPJ203209H, RPJ203826H);  b. Product No. DTMB1Q1: UDI 00643169705784 (Serial No. RPU201108H) (EXPANSION: Serial No. RPU201289H, RPU201290H, RPU201291H, RPU201292H, RPU201293H, RPU201295H, RPU201296H, RPU201297H, RPU201298H, RPU201299H, RPU201300H, RPU201301H, RPU201302H, RPU201303H, RPU201305H, RPU201306H, RPU201287H, RPU201288H, RPU201619H, RPU201621H, RPU201635H, RPU201304H);  c. Product No. DTMB1QQ: UDI 00643169929647 (Serial No. RPE219331H, RPE218183H), 00643169543386 (Serial No. RPE201417H, RPE204789H, RPE206207H, RPE207850H, RPE209095H, RPE212027H) (EXPANSION: Serial No. RPE215624H, RPE217014H, RPE200352H, RPE200394H, RPE201115H, RPE201328H, RPE202133H, RPE202941H, RPE203460H, RPE203771H, RPE203998H, RPE204209H, RPE204790H, RPE204791H, RPE204792H, RPE205432H, RPE206879H, RPE206886H, RPE208041H, RPE208241H, RPE208355H, RPE208369H, RPE208613H, RPE209037H, RPE209093H, RPE209135H, RPE209190H, RPE209194H, RPE209553H, RPE210227H, RPE210228H, RPE210672H, RPE210673H, RPE210734H, RPE210841H, RPE210844H, RPE210869H, RPE210870H, RPE210874H, RPE210875H, RPE211011H, RPE211012H, RPE211731H, RPE211732H, RPE211734H, RPE211736H, RPE211820H, RPE211858H, RPE211859H, RPE213564H, RPE214135H, RPE214544H, RPE214545H, RPE214546H, RPE215260H, RPE215628H, RPE216247H, RPE217013H, RPE217332H, RPE217335H, RPE217399H, RPE217443H, RPE217444H, RPE217446H, RPE217850H, RPE218146H, RPE218307H, RPE218308H, RPE219117H, RPE210877H, RPE215451H, RPE215625H, RPE215627H, RPE217445H, RPE217849H, RPE218148H, RPE215626H);   EXPANSION:  d. Product No. DTMB1D1: UDI 00643169705791 (Serial No. RPV200926H, RPV201075H, RPV201757H, RPV201758H)
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution.
  • Product Description
    Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Amplia MRI. Labeled as the following: || a. Amplia MRI CRT-D DF4 (Product No. DTMB1D4); || b. Amplia MRI Quad CRT-D DF1 (Product No. DTMB1Q1); || c. Amplia MRI Quad CRT-D DF4 (Product No. DTMB1QQ); || EXPANSION: || d. Amplia MRI CRT-D DF1 (Product No. DTMB1D1) || Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia. Some devices can also provide resynchronization therapy, including sequential biventricular pacing (CRT-D devices).
  • Manufacturer