SPDRL1 Sphera L DR MRI

Implantable Pulse Generator (IPG)

SPDRL1 Sphera L DR MRI

Device Survival Probability

ATDRL1_SPDRL1_SURV

	1 yr	2 yr	at 30.0 mo
%	100.0	100.0	100.0
%	100.0	100.0	100.0
#	234	150	100

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	FND
Mass	31.3 g
Volume	13.1 cc
Waveform	N/A
X-Ray ID	PHX

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IS-1 UNI/BI

Estimated Longevity

Amplitude Setting	500 Lead Ω	1000 Lead Ω
Low 2.5 V (A, RV)	11.6	13.3
Nominal 3.5 V (A, RV)	9.0	11.5
High 5.0 V (A, RV)	6.3	8.8

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	1
Estimated Active USA Implants	0
Normal Battery Depletions

US Market Release	2017-08-03
CE Approval Date	2017-06-16
Estimated WW Distribution	27128
Normal Battery Depletions

Malfunctions (USA)

Therapy Function Not Compromised
Therapy Function Compromised

Malfunctions (WW)

Therapy Function Not Compromised
Therapy Function Compromised

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