Devices › Implantable pulse generator, pacemaker (non-crt)
Device brand name · Implantable pulse generator pacemaker non-crt
Attain Over The Wire Lead: medical device reports filed with FDA
425 reports name it, 2011–2026. Manufacturer given most often on reports: Mpri. Product code LWP.
- 425
- device reports naming the brand
- 0% of all MAUDE reports · about 28 a year
- 51
- reports, 12 months to August 2026
- 50 in the 12 months before
- 32.5%
- classified as malfunction
- 41.5% across the product code
- 2.4%
- classified as death, as reported
- 10 reports · not verified by FDA
425 medical device reports received by FDA name the brand "Attain Over The Wire Lead" (implantable pulse generator pacemaker non-crt); the manufacturer given most often on reports is Mpri; received from March 2011 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
51 reports arrived in the 12 months to August 2026, close to the 50 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 (65.2%), malfunction (32.5%) and death (2.4%); 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 high capture threshold (34.4%), high impedance (15.3%) and failure to capture (14.6%). The patient problems coded most often are device overstimulation of tissue, undesired nerve stimulation and 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 |
|---|---|---|---|
| High capture threshold | 146 | 34.4% | 2.6% |
| High impedance | 65 | 15.3% | 9% |
| Failure to capture | 62 | 14.6% | 5.3% |
| Capturing problem | 30 | 7.1% | 1.8% |
| Impedance problem | 25 | 5.9% | 0.9% |
| Fracturea broken bone | 24 | 5.6% | 0.4% |
| Low impedance | 20 | 4.7% | 2% |
| Intermittent capture | 14 | 3.3% | 0.2% |
| Device dislodged or dislocated | 11 | 2.6% | 2.3% |
| Unstable capture threshold | 9 | 2.1% | 0.1% |
| Breakthe device broke | 6 | 1.4% | 0.5% |
| Over-sensing | 4 | 0.9% | 8.4% |
| Pacing problem | 4 | 0.9% | 5.6% |
| Insufficient device problem information | 3 | 0.7% | 0.7% |
| Connection problema connection problem | 1 | 0.2% | 1.6% |
| Detachment of device or device componentpart of the device came off | 1 | 0.2% | 0% |
| Device-device incompatibility | 1 | 0.2% | 0% |
| Difficult to removethe device was hard to remove | 1 | 0.2% | 0.2% |
| Extracardiac stimulation | 1 | 0.2% | 0.6% |
| Material split, cut or torn | 1 | 0.2% | 0% |
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 |
|---|---|---|
| Device overstimulation of tissue | 16 | 3.8% |
| Undesired nerve stimulation | 14 | 3.3% |
| Erosion | 12 | 2.8% |
| Muscle stimulation | 9 | 2.1% |
| Dyspneashortness of breath | 8 | 1.9% |
| Discomfortdiscomfort | 7 | 1.6% |
| Pocket erosion | 5 | 1.2% |
| Arrhythmia | 4 | 0.9% |
| Dizzinesslight-headedness or unsteadiness | 4 | 0.9% |
| Falla fall | 4 | 0.9% |
| Obstruction/occlusion | 4 | 0.9% |
| Chest painchest pain | 3 | 0.7% |
| Syncope/fainting | 3 | 0.7% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 2 | 0.5% |
| Bacteremia | 2 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Attain Over The Wire Lead | Product code LWP | All MAUDE reports |
|---|---|---|---|
| Reports | 425 | 157,494 | 26,136,888 |
| Share of that pool | — | 0.3% | 0% |
| Classified as death, per 1,000 reports | 24 | 12 | 9 |
| Classified as injury | 65.2% | 57.3% | 36.2% |
| Classified as malfunction | 32.5% | 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% |
| 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 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% |
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 Attain Over The Wire Lead reports
How many FDA reports name Attain Over The Wire Lead?
425 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 51 in the latest 12 months.
What kinds of events are reported?
injury (65.2%), malfunction (32.5%) and death (2.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
high capture threshold (34.4%), high impedance (15.3%), failure to capture (14.6%), capturing problem (7.1%) and impedance problem (5.9%). 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 Attain Over The Wire Lead 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.