Devices › Pulse-generator, pacemaker, external
Device brand name · External pulse generator
Asku: medical device reports filed with FDA
4,752 reports name it, 2006–2026. Manufacturer given most often on reports: Medtronic Milaca. Product code DTE.
- 4,752
- device reports naming the brand
- 0% of all MAUDE reports · about 239 a year
- 210
- reports, 12 months to August 2026
- 207 in the 12 months before
- 47.1%
- classified as malfunction
- 91.1% across the product code
- 1.1%
- classified as death, as reported
- 53 reports · not verified by FDA
FDA's MAUDE database holds 4,752 reports that name the brand "Asku" (external pulse generator), received between August 2006 and August 2026; the manufacturer given most often on reports is Medtronic Milaca. Spellings of one product vary from report to report.
210 reports arrived in the 12 months to August 2026, close to the 207 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 (50.9%), malfunction (47.1%) and death (1.1%); across all pulse-generator, pacemaker, external reports (product code DTE) death is recorded in 0.7% and malfunction in 91.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are patient device interaction problem (8.9%), loss of power (5.2%) and loss of osseointegration (4.8%). The patient problems coded most often are no patient involvement, skin infection and appropriate clinical signs, symptoms and conditions term/code not available. 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 13,075 reports carrying product code DTE. 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 |
|---|---|---|---|
| Patient device interaction problem | 421 | 8.9% | 0% |
| Loss of powerthe device lost power | 249 | 5.2% | 3% |
| Loss of osseointegration | 229 | 4.8% | 0% |
| Insufficient device problem information | 228 | 4.8% | 0.7% |
| Pacing problem | 193 | 4.1% | 3.1% |
| Mechanical problema mechanical problem | 178 | 3.7% | 12.7% |
| No display/image | 139 | 2.9% | 10.1% |
| Failure to power up | 129 | 2.7% | 4.4% |
| Device displays incorrect message | 82 | 1.7% | 3.2% |
| Defective devicethe device was defective | 75 | 1.6% | 0.5% |
| Breakthe device broke | 67 | 1.4% | 3.8% |
| Failure to capture | 63 | 1.3% | 1.5% |
| Output problem | 51 | 1.1% | 5.5% |
| Fracturea broken bone | 49 | 1% | 0% |
| Device sensing problem | 48 | 1% | 3.6% |
| Expulsion | 48 | 1% | 0% |
| Electrical /electronic property probleman electrical or electronic problem | 43 | 0.9% | 2.4% |
| No device output | 43 | 0.9% | 3.3% |
| High impedance | 42 | 0.9% | 0% |
| Crackthe device cracked | 40 | 0.8% | 1.3% |
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 |
|---|---|---|
| No patient involvement | 1,502 | 31.6% |
| Skin infection | 289 | 6.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 189 | 4% |
| Impaired healingslow healing | 146 | 3.1% |
| Inadequate osseointegration | 126 | 2.7% |
| Host-tissue reaction | 98 | 2.1% |
| Painpain, site not specified | 86 | 1.8% |
| Bacterial infectiona bacterial infection | 70 | 1.5% |
| Failure of implant | 52 | 1.1% |
| Tissue breakdown | 51 | 1.1% |
| Deaththe patient died; cause not stated by this term | 50 | 1.1% |
| Cardiac arrestthe heart stopped | 48 | 1% |
| Skin inflammation/ irritation | 48 | 1% |
| Cellulitisa skin infection | 46 | 1% |
| Head injurya head injury | 34 | 0.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Asku | Product code DTE | All MAUDE reports |
|---|---|---|---|
| Reports | 4,752 | 13,075 | 26,136,888 |
| Share of that pool | — | 36.3% | 0% |
| Classified as death, per 1,000 reports | 11 | 7 | 9 |
| Classified as injury | 50.9% | 7.7% | 36.2% |
| Classified as malfunction | 47.1% | 91.1% | 62.3% |
| Filed by the manufacturer | 84.7% | 98.1% | 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 DTE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Dual Chamber Temporary Pacemaker | 5,828 | 518 | 0.3% |
| Temporary External Pacemaker | 363 | 96 | 0.8% |
| Medtronic | 2,953 | 17 | 4.4% |
| Pacemaker | 221 | 15 | 5.9% |
| Medtronic Lead | 2,351 | 328 | 9.5% |
| CapSureFix Novus Lead MRI SureScan | 108,103 | 17,554 | 1% |
| CapSureFix Novus MRI SureScan | 18,909 | 3,243 | 1.3% |
| Carpentier-Edwards Perimount Magna Mitral Ease Pericardial Bioprostheses | 824 | 0 | 3.8% |
| Evera Xt Vr | 1,475 | 91 | 4.1% |
| Zoll | 221 | 0 | 14% |
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 Asku reports
How many FDA reports name Asku?
4,752 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 210 in the latest 12 months.
What kinds of events are reported?
injury (50.9%), malfunction (47.1%) and death (1.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
patient device interaction problem (8.9%), loss of power (5.2%), loss of osseointegration (4.8%), insufficient device problem information (4.8%) and pacing problem (4.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (84.7%), distributor reports (15.3%) 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 Asku 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.