8158
Prodigy SR
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | 10 yr | 11 yr | 12 yr | 13 yr | 14 yr | at 173 mo | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | ||||||
| % |  |
99.8 | 99.6 | 99.2 | 98.6 | 97.8 | 96.7 | 95.0 | 91.9 | 87.1 | 77.1 | 66.1 | 55.1 | 46.1 | 42.0 | 38.7 | ||||||
| # | 19684 | 17013 | 14714 | 12565 | 10706 | 9105 | 7661 | 6331 | 5010 | 3669 | 2526 | 1686 | 1136 | 433 | 110 |
- 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 | SSIR |
| Max. Delivered Energy | N/A |
| Connector Style | 5/6mm UNI |
|---|---|
| Serial Number Prefix | PEM |
| Mass | 22.5 g |
| Volume | 11.2 cc |
| Waveform | N/A |
| X-Ray ID | PEM |
5/6mm UNI
Estimated Longevity
| Amplitude Setting | 500 Lead Ω | 1000 Lead Ω |
|---|---|---|
| Low 2.5 V (A, RV) | 9.8 | 10.7 |
| Nominal 3.5 V (A, RV) | 8.0 | 9.5 |
| High 5.0 V (A, RV) | 6.4 | 8.1 |
Longevity estimates based on the following device usage. Pace/Sense Mode VVI ; Right Ventricle Pulse Width 0.4 ms; Lower Pace Rate 60 bpm; Right Ventricle Percent Paced 100 %; Upper Sensing Rate 130 ppm; Activity ON ; Hide this content
EOL Indication
From the point that the ERI is set, the pacemaker will operate at ERI conditions for approximately 2.5 months for typical pacemaker configurations during the normal operating life.
Distribution Data
| US Market Release | 1996-07-01 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 4090 |
| Estimated Active USA Implants | 640 |
| Normal Battery Depletions | 317 |
| US Market Release | 1996-07-01 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 4681 |
| Normal Battery Depletions | 347 |
Malfunctions (USA)
| Therapy Function Not Compromised | 2 |
|---|---|
| Possible Early Battery Depletion | 1 |
| Other | 1 |
| Therapy Function Compromised | 0 |
Malfunctions (WW)
| Therapy Function Not Compromised | 5 |
|---|---|
| Possible Early Battery Depletion | 1 |
| Other | 4 |
| Therapy Function Compromised | 0 |
Elective Replacement (ERI)
Telemetry indication. Rate and mode change to 65 ppm and VVI respectively (VOO/65 with magnet).
Data as of March 12, 2013