ReActiv8: medical device reports filed with FDA

435 reports name it, 2021–2026. Manufacturer given most often on reports: Mainstay Medical. Product code QLK.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

435
device reports naming the brand: 0% of all MAUDE reports · about 89 a year; 174
reports, 12 months to August 2026: 118 in the 12 months before; 44.6%
classified as malfunction: 44.6% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

FDA's MAUDE database holds 435 reports that name the brand "ReActiv8" (reactiv8 implantable pulse generator), received between August 2021 and August 2026; the manufacturer given most often on reports is Mainstay Medical. Spellings of one product vary from report to report.

174 reports arrived in the 12 months to August 2026, up 47% from 118 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (55.4%) and malfunction (44.6%); across all stimulator, neuromuscular, lower back muscles, totally implanted for pain relief reports (product code QLK) death is recorded in 0% and malfunction in 44.6%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are failure to conduct (41.1%), migration (5.3%) and failure to deliver shock/stimulation (1.4%). The patient problems coded most often are failure of implant, implant pain and post operative wound infection. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Reports by month, five years

Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury55.4%241

Malfunction44.6%194

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%435

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 448 reports carrying product code QLK. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)	Reports	Share	Share across product code
Failure to conduct	179	41.1%	41.3%
Migrationthe device moved from where it was placed	23	5.3%	5.1%
Failure to deliver shock/stimulation	6	1.4%	1.6%
Fracturea broken bone	2	0.5%	0.9%
Device damaged by another device	1	0.2%	0.2%
Electrical /electronic property probleman electrical or electronic problem	1	0.2%	0.2%
High impedance	1	0.2%	0.2%
Improper or incorrect procedure or method	1	0.2%	0.2%
Malposition of device	1	0.2%	0.2%
Mechanical problema mechanical problem	1	0.2%	0.2%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)	Reports	Share
Failure of implant	185	42.5%
Implant pain	123	28.3%
Post operative wound infection	23	5.3%
Wound infectionan infected wound	8	1.8%
Impaired healingslow healing	7	1.6%
Falla fall	6	1.4%
Painpain, site not specified	5	1.1%
Bacterial infectiona bacterial infection	4	0.9%
Discomfortdiscomfort	4	0.9%
Cramp(s) /muscle spasm(s)	3	0.7%
Rashskin rash	3	0.7%
Skin inflammation/ irritation	3	0.7%
Wound dehiscencea wound reopened	3	0.7%
Appropriate clinical signs, symptoms and conditions term/code not available	2	0.5%
Inflammationinflammation	2	0.5%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	ReActiv8	Product code QLK	All MAUDE reports
Reports	435	448	26,136,888
Share of that pool	—	97.1%	0%
Classified as death, per 1,000 reports	0	0	9
Classified as injury	55.4%	55.4%	36.2%
Classified as malfunction	44.6%	44.6%	62.3%
Filed by the manufacturer	100%	99.8%	94.9%

Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Questions about ReActiv8 reports

How many FDA reports name ReActiv8?

435 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 174 in the latest 12 months.

What kinds of events are reported?

injury (55.4%) and malfunction (44.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

failure to conduct (41.1%), migration (5.3%), failure to deliver shock/stimulation (1.4%), fracture (0.5%) and device damaged by another device (0.2%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that ReActiv8 was at fault?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.