PROPONENT MRI EL DR Pacemaker L231 - Dual-chamber pacemaker, rate-responsive

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Boston Scientific Pty Ltd

Class:

AIMD

Authorization status:

Included

Patient Information leaflet

MECHANICAL SPECIFI CATIONS
SIZE (CM)
CONNECTOR TYPE
MODEL
TYPE
(W X H X D)
MASS (G)
VOLUME (CC)
(RA RV LV)
L231
DR
4.45 x 5.88 x 0.75
29.2
14.2
RA: IS1 – RV: IS1
• Settings: LRL 60bpm, ventricular and atrial settings of 0.4 ms
pacing pulse width; sensors On; EGM Onset On. These calculations also
assume that the pulse generator spends 6 months in Storage mode during
shipping and storage, the ZIP
™
telemetry use for 1 hour at
implant time and for 40 minutes annually for in-clinic follow-up
checks.
• Power Supply: lithium-carbon monofl uoride cell; Boston Scientifi
c; 402294.
***No MV Sensor
ADDITIONAL LONGEVITY INFORMATION
PROPONENT
™ EL MRI PACING SYSTEM
ImageReady
™
MR Conditional Pacing System
Model L231
• Provides an ImageReady
™
MR Conditional pacing system* at 3T and 1.5T, full body, with no time
limitations, with automatic MRI timeout feature to optimize workfl ow
in the MR environment
• Extended Longevity device projected to last up to 16.7 years**
• Atrial Arrhythmia Report provides a comprehensive and proactive
approach for comorbidity
management
• RF telemetry for wireless transmission of information and effi
ciency in the operating room
and follow-up setting
• Automatic Daily Monitoring with the LATITUDE
™
NXT Patient Management System
• Automaticity with PaceSafe
™
RV and RA, providing dynamic adjustment of pacing outputs to
ensure capture and Automatic Gain Control to dynamically adjust the
sensitivity in both the
atrium and the ventricle, to maximize effi ciency and ease of use
• RightRate
™
MV sensor is the only sensor clinically proven to restore chronotropic
competence
1
• RYTHMIQ
™
, designed to minimize unnecessary RV pacing without clinically
signifi cant pauses,
therefore reducing the risk of HF development
• Enhanced features and diagnostics including Respiratory Rate
Trend, designed to provide
you with greater insight into your patient’s disease progression
based on the patient’s
own respiration
• POST function to facilitate patient follow up w

Summary of Product characteristics

PMA P150012: FDA Summary of Safety and Effectiveness Data
Page 1 of 82
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
I.
GENERAL INFORMATION
Device Generic
Name:
Pulse Generator (PG): Implantable Pacemaker
Lead: Steroid-eluting, endocardial, bipolar, pace/sense lead
Lead stabilizer accessory
Stylet accessories
Device Trade
Name:
ImageReady
TM
MR Conditional Pacing System, consisting of:
The following Implantable PGs:

INGENIO™ MRI Pacemaker, Models K175, K176 & K177

VITALIO™ MRI Pacemaker, Models K275, K276 & K277

FORMIO™ MRI Pacemaker, Model K279

ESSENTIO™ MRI Pacemaker, Models L110, L111 & L131

PROPONENT™ MRI Pacemaker, Models L210, L211 & L231

ACCOLADE™ MRI Pacemaker, Models L310, L311 & L331
INGEVITY™ MRI Pace/Sense Lead:

Models 7731 & 7732 (Passive-fixation, Ventricular straight)

Models 7735 & 7736 (Passive-fixation, Preformed Atrial J)

Models 7740, 7741 & 7742 (Active-fixation, straight)
Accessories:

Slit Suture Sleeve Accessory, Model 6402

ZOOM® LATITUDE
TM
Programing System, Model 3120

Programmer Software Application, Model 2869 v2.02

IS-1 Port Plug, Model 7145
Other Leads and Accessories:
INGEVITY™ Non-MRI Pace/Sense Lead:

Models 7631 & 7632 (Passive-fixation, Ventricular straight)

Models 7635 & 7636 (Passive-fixation, Preformed Atrial J)

Models 7640, 7641 & 7642 (Active-fixation, straight)
Other Accessories:

Delivery Stylet, Models 5003, 5004, 5005, 5012, 5013, 5014
Device Procode:
LWP
NVN
PMA P150012: FDA Summary of Safety and Effectiveness Data
Page 2 of 82
Applicant’s Name
and Address:
Boston Scientific Corporation
4100 Hamline Avenue North
St. Paul, Minnesota 55112-5798
Date of Panel
Recommendation:
None
PMA Number:
P150012
Date of Notice of
Approval to
Applicant:
April 25, 2016
II. INDICATIONS FOR USE
II. A.
INGENIO AND ACCOLADE MRI PACEMAKER DEVICE INDICATIONS
The Ingenio and Accolade MRI pacemakers are indicated for the
treatment of the
following conditions:

Symptomatic paroxysmal or permanent second- or third-deg