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 at 118.0 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
% Including Normal Battery Depletion 99.9 99.9 99.8 99.7 99.3 98.6 96.4 86.0 61.6 28.0
#   96636 86514 75921 64990 53468 42216 30463 17472 5676 169
  • 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 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

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

Distribution Data

US Market Release2006-07-17
CE Approval Date2005-09-20
Registered USA Implants114861
Estimated Active USA Implants67354
Normal Battery Depletions5129
US Market Release2006-07-17
CE Approval Date2005-09-20
Estimated WW Distribution170780
Normal Battery Depletions5142
Information

Malfunctions (USA)

Therapy Function Not Compromised 9
Electrical Component 7
Electrical Interconnect 2
Therapy Function Compromised 8
Electrical Component 4
Other 4
Information

Malfunctions (WW)

Therapy Function Not Compromised 15
Electrical Component 13
Electrical Interconnect 2
Therapy Function Compromised 12
Electrical Component 8
Other 4
Information

Recommended Replacement (RRT)

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

Data as of February 3, 2017

www.medtronic.com/productperformance 476050