Devices › Implantable pulse generator, pacemaker (non-crt)
Device brand name · Implantable pulse generator
Ingenio: medical device reports filed with FDA
7,539 reports name it, 2012–2026. Manufacturer given most often on reports: Guidant Crm Clonmel Ireland. Product code LWP.
- 7,539
- device reports naming the brand
- 0% of all MAUDE reports · about 529 a year
- 493
- reports, 12 months to August 2026
- 624 in the 12 months before
- 29.4%
- classified as malfunction
- 41.5% across the product code
- 0.8%
- classified as death, as reported
- 57 reports · not verified by FDA
7,539 medical device reports received by FDA name the brand "Ingenio" (implantable pulse generator); the manufacturer given most often on reports is Guidant Crm Clonmel Ireland; received from April 2012 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
493 reports arrived in the 12 months to August 2026, down 21% from 624 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 (69.9%), malfunction (29.4%) and death (0.8%); 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 incorrect, inadequate or imprecise result or readings (18.8%), over-sensing (15.5%) and premature discharge of battery (14.8%). The patient problems coded most often are syncope, complaint, ill-defined and pocket erosion. 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 |
|---|---|---|---|
| Incorrect, inadequate or imprecise result or readings | 1,419 | 18.8% | 4.3% |
| Over-sensing | 1,170 | 15.5% | 8.4% |
| Premature discharge of battery | 1,117 | 14.8% | 22.3% |
| Pacing problem | 1,094 | 14.5% | 5.6% |
| High impedance | 873 | 11.6% | 9% |
| Ambient noise problem | 602 | 8% | 2% |
| Failure to capture | 532 | 7.1% | 5.3% |
| Device sensing problem | 450 | 6% | 2.2% |
| Defective devicethe device was defective | 407 | 5.4% | 3.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 392 | 5.2% | 2.9% |
| Battery problema problem with the battery | 383 | 5.1% | 3.4% |
| Low impedance | 314 | 4.2% | 2% |
| Signal artifact/noise | 204 | 2.7% | 3.1% |
| Capturing problem | 168 | 2.2% | 1.8% |
| Connection problema connection problem | 160 | 2.1% | 1.6% |
| Under-sensing | 114 | 1.5% | 2.1% |
| Impedance problem | 110 | 1.5% | 0.9% |
| Device displays incorrect message | 105 | 1.4% | 7.9% |
| Interrogation problem | 102 | 1.4% | 1.3% |
| Communication or transmission problemthe device could not communicate or transmit | 99 | 1.3% | 0.6% |
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 |
|---|---|---|
| Syncopefainting | 375 | 5% |
| Complaint, ill-defined | 217 | 2.9% |
| Pocket erosion | 216 | 2.9% |
| Dizzinesslight-headedness or unsteadiness | 166 | 2.2% |
| Cardiac arrestthe heart stopped | 162 | 2.1% |
| Syncope/fainting | 142 | 1.9% |
| Sepsisa severe body-wide response to infection | 133 | 1.8% |
| Atrial fibrillationan irregular heart rhythm | 109 | 1.4% |
| Asystole | 95 | 1.3% |
| Falla fall | 84 | 1.1% |
| Bradycardiaslow heart rate | 81 | 1.1% |
| Erosion | 59 | 0.8% |
| Deaththe patient died; cause not stated by this term | 53 | 0.7% |
| Device overstimulation of tissue | 51 | 0.7% |
| Endocarditis | 38 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Ingenio | Product code LWP | All MAUDE reports |
|---|---|---|---|
| Reports | 7,539 | 157,494 | 26,136,888 |
| Share of that pool | — | 4.8% | 0% |
| Classified as death, per 1,000 reports | 8 | 12 | 9 |
| Classified as injury | 69.9% | 57.3% | 36.2% |
| Classified as malfunction | 29.4% | 41.5% | 62.3% |
| Filed by the manufacturer | 100% | 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% |
| 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 Spiral S | 2,816 | 424 | 0.5% |
| 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 Ingenio reports
How many FDA reports name Ingenio?
7,539 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 493 in the latest 12 months.
What kinds of events are reported?
injury (69.9%), malfunction (29.4%) and death (0.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
incorrect, inadequate or imprecise result or readings (18.8%), over-sensing (15.5%), premature discharge of battery (14.8%), pacing problem (14.5%) and high impedance (11.6%). 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 Ingenio 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.