SPDR01 Sphera DR MRI

Implantable Pulse Generator (IPG)

SPDR01 Sphera DR MRI

Device Survival Probability

SPDR01_SURV

		at 0.0 mo

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.

Customer Communications For This Model

There are no communications for this model.

Product Characteristics

Generator Type	IPG
NBD Code	DDDR
Max. Delivered Energy	N/A

Connector Style	IS-1 UNI/BI
Serial Number Prefix	FNC
Mass	27.1 g
Volume	12.1 cc
Waveform	N/A
X-Ray ID	PHX

Hide this content

IS-1 UNI/BI

Estimated Longevity

Amplitude Setting	500 Lead Ω	1000 Lead Ω
Low 2.5 V (A, RV)	9.5	10.8
Nominal 3.5 V (A, RV)	7.4	9.5
High 5.0 V (A, RV)	5.2	7.3

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 %; Upper Sensing Rate 130 ppm; Atrial Percent Paced 100 %; Atrial Fib Percent of Time 0 % Hide this content

Distribution Data

US Market Release	2017-08-03
CE Approval Date	2017-06-16
Registered USA Implants
Estimated Active USA Implants
Normal Battery Depletions

US Market Release	2017-08-03
CE Approval Date	2017-06-16
Estimated WW Distribution	79646
Normal Battery Depletions

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised

Malfunctions (WW)

Therapy Function Not Compromised	3
Electrical Component	3
Therapy Function Compromised	0

EOL Indicator

180 days from RRT

Recommended Replacement (RRT)

Battery voltage less than or equal to 2.5 V, or battery voltage less than or equal to 2.59 V and battery impedance at 3000 ohms

Data as of November 20, 2024