Devices › Implantable pulse generator, pacemaker (non-crt)
Device brand name · Implantable pulse generator pacemaker non-crt
ACUITY X4 Spiral S: medical device reports filed with FDA
2,816 reports name it, 2018–2026. Manufacturer given most often on reports: Boston Scientific. Product code LWP.
- 2,816
- device reports naming the brand
- 0% of all MAUDE reports · about 364 a year
- 424
- reports, 12 months to August 2026
- 414 in the 12 months before
- 38.8%
- classified as malfunction
- 41.5% across the product code
- 0.5%
- classified as death, as reported
- 15 reports · not verified by FDA
FDA's MAUDE database holds 2,816 reports that name the brand "ACUITY X4 Spiral S" (implantable pulse generator pacemaker non-crt), received between October 2018 and August 2026; the manufacturer given most often on reports is Boston Scientific. Spellings of one product vary from report to report.
424 reports arrived in the 12 months to August 2026, close to the 414 of 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 (60.7%), malfunction (38.8%) and death (0.5%); across all implantable pulse generator, pacemaker (non-crt) reports (product code LWP) death is recorded in 1.2% and malfunction in 41.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are failure to capture (15.9%), device dislodged or dislocated (11.9%) and high capture threshold (11.7%). The patient problems coded most often are sepsis, device overstimulation of tissue and bacterial 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
Who filed the report
Grey bar: all 157,494 reports carrying product code LWP. 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 capture | 448 | 15.9% | 5.3% |
| Device dislodged or dislocated | 336 | 11.9% | 2.3% |
| High capture threshold | 329 | 11.7% | 2.6% |
| High impedance | 288 | 10.2% | 9% |
| Defective devicethe device was defective | 244 | 8.7% | 3.5% |
| Material integrity problema problem with the device material | 126 | 4.5% | 1.7% |
| Positioning problem | 106 | 3.8% | 0.3% |
| Over-sensing | 87 | 3.1% | 8.4% |
| Pacing problem | 73 | 2.6% | 5.6% |
| Difficult to insertthe device was hard to insert | 61 | 2.2% | 0.2% |
| Signal artifact/noise | 54 | 1.9% | 3.1% |
| Insufficient device problem information | 50 | 1.8% | 0.7% |
| Extracardiac stimulation | 42 | 1.5% | 0.6% |
| Failure to read input signal | 42 | 1.5% | 0.7% |
| Fracturea broken bone | 34 | 1.2% | 0.4% |
| Low impedance | 24 | 0.9% | 2% |
| Impedance problem | 23 | 0.8% | 0.9% |
| Difficult to removethe device was hard to remove | 18 | 0.6% | 0.2% |
| Device sensing problem | 16 | 0.6% | 2.2% |
| Off-label use | 10 | 0.4% | 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 |
|---|---|---|
| Sepsisa severe body-wide response to infection | 252 | 8.9% |
| Device overstimulation of tissue | 109 | 3.9% |
| Bacterial infectiona bacterial infection | 64 | 2.3% |
| Pocket erosion | 64 | 2.3% |
| Muscle stimulation | 22 | 0.8% |
| Endocarditis | 21 | 0.7% |
| Painpain, site not specified | 20 | 0.7% |
| Twiddlers syndrome | 19 | 0.7% |
| Erosion | 14 | 0.5% |
| Swelling/ edema | 14 | 0.5% |
| Purulent discharge | 12 | 0.4% |
| Discomfortdiscomfort | 11 | 0.4% |
| Pericardial effusionfluid around the heart | 11 | 0.4% |
| Staphylococcus aureus | 10 | 0.4% |
| Vascular dissection | 10 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | ACUITY X4 Spiral S | Product code LWP | All MAUDE reports |
|---|---|---|---|
| Reports | 2,816 | 157,494 | 26,136,888 |
| Share of that pool | — | 1.8% | 0% |
| Classified as death, per 1,000 reports | 5 | 12 | 9 |
| Classified as injury | 60.7% | 57.3% | 36.2% |
| Classified as malfunction | 38.8% | 41.5% | 62.3% |
| Filed by the manufacturer | 99.9% | 99.3% | 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."
Other brands with product code LWP
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Assurity Mri | 18,995 | 2,035 | 1.8% |
| Teligen | 16,537 | 47 | 0.6% |
| Ingenio | 7,539 | 493 | 0.8% |
| Cognis | 8,694 | 6 | 1.5% |
| Ingevity | 9,039 | 299 | 0.9% |
| Accolade | 4,335 | 4 | 1.5% |
| Attain Otw | 7,773 | 0 | 9.1% |
| Energen | 5,237 | 0 | 0.6% |
| Energen Icd | 3,151 | 142 | 0.2% |
| ACUITY X4 Straight | 2,672 | 382 | 0.4% |
| Incepta Icd | 2,497 | 126 | 0.1% |
| Altrua | 4,122 | 0 | 2.4% |
| Incepta | 4,327 | 0 | 0.7% |
| Revo MRI SureScan | 1,996 | 12 | 2.9% |
| Acuity | 3,848 | 6 | 1% |
Ordered by report count for navigation only. 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 also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about ACUITY X4 Spiral S reports
How many FDA reports name ACUITY X4 Spiral S?
2,816 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 424 in the latest 12 months.
What kinds of events are reported?
injury (60.7%), malfunction (38.8%) and death (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to capture (15.9%), device dislodged or dislocated (11.9%), high capture threshold (11.7%), high impedance (10.2%) and defective device (8.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that ACUITY X4 Spiral S 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.