SenzaRecalls & reported problems across all models
Nevro Corp. · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,854
- Deaths reported
- 473
- Injuries reported
- 2,359
- Recalls
- 0
We found 13 models of Senza by Nevro Corp. in the FDA's device registry (GUDID). Together they are named in 2,854 adverse event reports in the FDA's MAUDE database, received between Nov 15, 2015 and Sep 30, 2026 — classified as 473 deaths, 2,359 injuries, 22 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (250 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Senza problems
Device problems
- Adverse Event Without Identified Device or Use Problem2,795
- Insufficient Device Problem Information250
- Detachment of Device or Device Component13
- Fracture10
- Migration9
- Appropriate Device Problem Term/Code Not Available6
- Break6
- Inappropriate/Inadequate Shock/Stimulation4
Patient problems
- Unspecified Infection961
- Insufficient Information646
- Pain202
- Death195
- Implant Pain117
- Wound Dehiscence101
- Hematoma89
- Bacterial Infection84
Senza models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Senza® NIPG1500Stimulator, Spinal-Cord, Totally Implanted For Pain Relief432 deaths1,792 reports
- Senza NIPG3000Stimulator, Spinal-Cord, Totally Implanted For Pain Relief35 deaths722 reports
- Senza LEAD1058-50BPStimulator, Spinal-Cord, Totally Implanted For Pain Relief145 reports
- Senza LEAD1058-70BPStimulator, Spinal-Cord, Totally Implanted For Pain Relief85 reports
- Senza TLEAD1058-50BStimulator, Spinal-Cord, Totally Implanted For Pain Relief38 reports
- Senza TLEAD1058-70BStimulator, Spinal-Cord, Totally Implanted For Pain Relief1 death23 reports
- Senza® NIPG1000Stimulator, Spinal-Cord, Totally Implanted For Pain Relief5 deaths22 reports
- Senza TLEAD1058-50BStimulator, Spinal-Cord, Totally Implanted For Pain Relief13 reports
- Senza LEAD1058-90BPStimulator, Spinal-Cord, Totally Implanted For Pain Relief7 reports
- Senza TLEAD1058-70BStimulator, Spinal-Cord, Totally Implanted For Pain Relief3 reports
- Senza EXTS3500Stimulator, Spinal-Cord, Totally Implanted For Pain Relief2 reports
- Senza® CHGR1000Stimulator, Spinal-Cord, Totally Implanted For Pain Relief1 report
- Senza ACCK4310Stimulator, Spinal-Cord, Totally Implanted For Pain Relief1 report
Recent Senza adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient acquired an infection. A medical assessment from the physician regarding the nature of the infection was not available. The patient was hospitalized, and there have been no reports of further complications regarding this event.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 50946398 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient developed an infection at the lead incision site. A medical assessment from the physician regarding the nature of the infection was not available. The patient was initially treated with oral antibiotics; however, the infection did not resolve. The patient was subsequently hospitalized, treated with IV antibiotics, and underwent lead extraction. No further complications related to this event have been reported.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 50945752 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced incontinence, increased back pain, generalized pain, numbness, weakness, and other neurological symptoms. A medical assessment from the physician regarding the cause of the reported symptoms was not available. The patient subsequently underwent device removal. No further complications related to this event have been reported.
Patient problems: Back pain; Incontinence; Neuropathy; Pain
MAUDE report 50903673 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Burning Sensation; Nerve Damage; Pain
MAUDE report 50903660 ↗InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced discomfort at the implant site. A medical assessment regarding the nature of the reported issue was not available. The patient had the device removed, and no further complications have been reported related to this event.
Patient problems: Discomfort
MAUDE report 50899689 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient developed a bacterial infection (Staphylococcal infection) around the battery. A medical assessment from the physician regarding the nature of the infection was not available. The patient had the device removed and there have been no reports of further complications regarding this event.
Patient problems: Bacterial Infection
MAUDE report 50886481 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 50860404 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient acquired an infection at the implant site. A medical assessment from the physician regarding the nature of the infection was not available. The patient had the device removed and there have been no reports of further complications regarding this event.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 50859205 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced back pain. A medical assessment from the physician regarding the cause of the reported event was not available. The patient was hospitalized. There have been no reports of further complications regarding this event.
Patient problems: Back pain
MAUDE report 50855093 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient acquired an infection. A medical assessment from the physician regarding the nature of the infection was not available. The patient had the device removed and there have been no reports of further complications regarding this event.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 50854742 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient developed an infection at the lead incision site. The physician believed that the infection was related to the implant surgery. The patient was admitted to the hospital, and the device was removed. The patient was treated with intravenous antibiotics. No further complications related to this event have been reported.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 50853957 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient acquired an infection. A medical assessment from the physician regarding the nature of the infection was not available. The patient was treated with oral antibiotics, there have been no reports of further complications regarding this event.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 50853722 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient developed cellulitis at the implant site. A medical assessment from the physician regarding the nature of the infection was not available. The patient was treated with oral and topical medications, as well as intravenous antibiotics. No further complications related to this event have been reported.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 50853307 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced pain. A medical assessment from the physician regarding the cause of the reported event was not available. The patient had the device removed. There have been no reports of further complications regarding this event.
Patient problems: Pain
MAUDE report 50817750 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced pain at implant site. A medical assessment regarding the nature of the reported issue was not available. The patient was hospitalized, and no further complications have been reported related to this event.
Patient problems: Implant Pain
MAUDE report 50817720 ↗
Other Nevro Corp. products
All Nevro Corp. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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