28
Jul
2004

Medtronic Inc Class II

0

Company: Medtronic Inc
Date of Enforcement Report: 7/28/04
Class: II

PRODUCT
a) Kappa Model 701 Implantable Pulse Generators (IPGs)
are pacemaker devices that provide therapies for
bradycardia (slow heart rhythm). Model 701 KVDD
IPGs provide atrial sensing and do not provide
atrial pacing by design intent; these devices
provide ventricular sensing and ventricular pacing;
also by design. Recall # Z-1109-04;
b) Kappa Model 901 Implantable Pulse Generators
(IPGs) are pacemaker devices that provide therapies
for bradycardia (slow heart rhythm). Model 901 KVDD
IPGs provide atrial sensing and do not provide
atrial pacing by design intent; these devices
provide ventricular sensing and ventricular pacing;
also by design. Recall # Z-1110-04.

REASON
Potential problems with the programmer interface. Kappa Model KVDD 701/901 IPG’s that were processed through the Distribution Center Restock Tester (DCRT) have an inadvertent error of having the atrial amplitude programmed on and set to 3.5V. For the Kappa KVDD device, atrial amplitude programmed on is considered an invalid parameter by the programmer software, consequently the Model 9790 or 2090 Programmer will not allow a Real Time Telemetry (RTT) measurement to be performed upon initial device interrogation or via battery and lead impedance measurement screens. Therefore, battery measurements, estimated longevity, and lead impedance measurements are not available via RTT.

CODE
a) Serial numbers:PHP639142S, PHP639071S, PHP641397S,
PHP641427S, PHP639084S, PHP637588S, PHP641973S,
PHP638150S, and PHP640598S;
b) Serial numbers:PLE100772H, PLE100708H, PLE100832H,
PLE721316S, PLE721730S, PLE722475S, PLE722599S,
PLE722786S, PLE721384S, PLE722723S, PLE723479S,
PLE723562S, PLE722865S, PLE722865S, PLE723451S,
PLE721760S, PLE721309S, PLE723579S, PLE723754S,
PLE722993S, and PLE723183S.

RECALLING FIRM/MANUFACTURER
Medtronic Inc., Cardiac Rhythm Management, Fridley, MN, by letter on April 30, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
30 devices.

DISTRIBUTION
Nationwide and Internationally.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

SoftwareCPR Training Courses:

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future.  Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply.  Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering:  TBD

Email training@softwarecpr.com to request a special pre-registration discount.  Limited number of pre-registration coupons.

Registration Link:

TBD

 

 

Being Agile & Yet Compliant (Public or Private)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for scheduling!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

Virtual via Zoom

Registration Link:

Register Now

 

 

Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering:  TBD

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
office@softwarecpr.com
Partners located in the US (CA, FL, MA, MN, TX) and Canada.