VEDR01 Versa DR
Implantable Pulse Generator (IPG)
VEDR01 Versa DR
Information

Device Survival Probability

VEDR01_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 11 yr at 140.0 mo                  
% Excluding Normal Battery Depletion 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0                  
% Including Normal Battery Depletion 99.8 99.8 99.7 99.6 99.2 98.6 97.1 91.3 76.7 59.6 50.7 47.8                  
#   101479 93749 85074 76898 69180 60937 51255 38926 23814 10690 2840 357                  
  • 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

Product Characteristics

Generator Type IPG
NBD Code DDDR
Max. Delivered Energy N/A
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Connector Style IS-1 UNI/BI
Serial Number Prefix NWH, PWH
Mass 27.1 g
Volume 12.1 cc
Waveform N/A
X-Ray ID PWH, 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) 7.4 | 9.1* 8.2 | 10.3*
Nominal 3.5 V (A, RV) 6.0 | 7.2* 7.4 | 9.0*
High 5.0 V (A, RV) 4.5 | 5.1* 6.0 | 7.0*
Footnote

*The second longevity numbers provided apply to the N-series Versa VEDR01 product. The N-series products have increased longevity because of improved electronic circuitry. Click on "Other Articles" for more information on the N-series longevity. 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 Release2006-07-17
CE Approval Date2005-09-20
Registered USA Implants118686
Estimated Active USA Implants60573
Normal Battery Depletions8631
US Market Release2006-07-17
CE Approval Date2005-09-20
Estimated WW Distribution176666
Normal Battery Depletions8666
Information

Malfunctions (USA)

Therapy Function Not Compromised 13
Electrical Component 9
Electrical Interconnect 2
Possible Early Battery Depletion 2
Therapy Function Compromised 11
Electrical Component 7
Other 4
Information

Malfunctions (WW)

Therapy Function Not Compromised 19
Electrical Component 15
Electrical Interconnect 2
Possible Early Battery Depletion 2
Therapy Function Compromised 15
Electrical Component 11
Other 4
Information

EOS Indication

Prolonged Service period is 3 months after RRT/ERI assuming 100% pacing at the listed parameter settings. Reprogramming of pacing parameters may reduce 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 November 8, 2019

www.medtronic.com/productperformance 726050