KDR806
Kappa 800 DR
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | at 109 mo | ||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 99.9 | 99.9 | 99.9 | 99.9 |
| % |  |
100.0 | 99.8 | 99.6 | 99.4 | 98.6 | 96.5 | 87.6 | 64.8 | 28.1 | 23.8 |
| # | 4585 | 4252 | 3915 | 3586 | 3257 | 2937 | 2390 | 1336 | 221 | 168 |
- 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.
Advisories For This Model
- There are no advisories for this model.
Product Characteristics
| Generator Type | IPG |
|---|---|
| NBD Code | DDD/RO |
| Max. Delivered Energy | N/A |
| Connector Style | 5/6mm UNI |
|---|---|
| Serial Number Prefix | PLA |
| Mass | 28.5 g |
| Volume | 14.2 cc |
| Waveform | N/A |
| X-Ray ID | PLA |
5/6mm UNI
Estimated Longevity
| Amplitude Setting | 500 Lead Ω | 1000 Lead Ω |
|---|---|---|
| Low 2.5 V (A, RV) | 7.7 | 8.6 |
| Nominal 3.5 V (A, RV) | 6.3 | 7.7 |
| High 5.0 V (A, RV) | 4.4 | 6.0 |
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 %; Upper Sensing Rate 130 ppm; Atrial Percent Paced 100 %; Atrial Fib Percent of Time 0 %Hide this content
EOL Indication
From the point that the ERI is set, the pacemaker will operate at ERI conditions for approximately three months for typical pacemaker configurations during the normal operating life.
Distribution Data
| US Market Release | 2002-01-09 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | |
| Estimated Active USA Implants | |
| Normal Battery Depletions |
| US Market Release | 2002-01-09 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 3 |
| Normal Battery Depletions |
Malfunctions (USA)
| Therapy Function Not Compromised | |
|---|---|
| Therapy Function Compromised |
Malfunctions (WW)
| Therapy Function Not Compromised | |
|---|---|
| Therapy Function Compromised |
Elective Replacement (ERI)
Replacement message on programmer. Nonmagnet mode VVI 65 ppm Magnet mode VOO 65 pp
Data as of March 12, 2013