RED01 Relia D
Implantable Pulse Generator (IPG)
RED01 Relia D
Information

Device Survival Probability

ADDR01_ADDR03_ADDR06_ADD01_SURV
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    1 yr 2 yr 3 yr 4 yr 5 yr 6 yr 7 yr 8 yr 9 yr 10 yr at 125.0 mo                    
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0                    
% Including Normal Battery Depletion 99.9 99.9 99.8 99.7 99.4 99.0 97.8 92.8 77.9 45.0 24.9                    
#   409196 377248 342433 306796 263469 218124 171117 120244 61192 11396 1479                    
  • Including Normal Battery Depletion – This curve includes devices that have reached at least 80% of expected longevity. This curve is most representative of clinical performance and how long the device will last.
  • Excluding Normal Battery Depletion – This is the malfunction free survival curve.
Information

Advisories For This Model

  • There are no advisories for this model.

Performance Notes For This Model

Information

Product Characteristics

Generator Type IPG
NBD Code DDD
Max. Delivered Energy N/A
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Connector Style IS-1 UNI/BI
Serial Number Prefix NWW
Mass 27.1 g
Volume 12.1 cc
Waveform N/A
X-Ray ID PWB
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IS-1 UNI/BI
Information

Estimated Longevity

Amplitude Setting 500 Lead Ω 1000 Lead Ω
Low 2.5 V (A, RV) 9.1 10.3
Nominal 3.5 V (A, RV) 7.2 9.0
High 5.0 V (A, RV) 5.1 7.0
Footnote

Longevity estimates based on the following device usage. Pace/Sense Mode DDD ; Atrial Pulse Width 0.4 ms; Right Ventricle Pulse Width 0.4 ms; Lower Pace Rate 60 bpm; Right Ventricle Percent Paced 100 %; EGM Prestorage ON ; Upper Sensing Rate 130 ppm; Atrial Percent Paced 100 %; EGM Prestorage ON Time 1 ; Atrial Fib Percent of Time 0 %Hide this content

Information

Distribution Data

US Market Release
CE Approval Date2008-05-07
Registered USA Implants
Estimated Active USA Implants
Normal Battery Depletions
US Market Release
CE Approval Date2008-05-07
Estimated WW Distribution54291
Normal Battery Depletions28
Information

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised
Information

Malfunctions (WW)

Therapy Function Not Compromised 4
Electrical Component 2
Possible Early Battery Depletion 2
Therapy Function Compromised 0
Information

EOS Indication

The prolonged service period is 3 months after RRT/ERI and assumes 100% pacing at VVI/65 and the listed parameter values. Reprogramming of parameters may shorten the duration of the prolonged service period.

Information

Recommended Replacement (RRT)

Telemetry indication. Rate and Mode change to 65 ppm and VVI (VOO/65 with magnet).

Data as of October 12, 2018

www.medtronic.com/productperformance 626050