Devices › Pulse generator, permanent, implantable
Device brand name · Pulse generator permanent implantable
Azure: medical device reports filed with FDA
919 reports name it, 2018–2019. Manufacturer given most often on reports: Medtronic Puerto Rico Operations. Product code NVZ.
- 919
- device reports naming the brand
- 0% of all MAUDE reports · about 109 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 43.2%
- classified as malfunction
- 43.5% across the product code
- 1.8%
- classified as death, as reported
- 17 reports · not verified by FDA
919 medical device reports received by FDA name the brand "Azure" (pulse generator permanent implantable); the manufacturer given most often on reports is Medtronic Puerto Rico Operations; received from February 2018 to May 2019. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none 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%), malfunction (43.2%) and death (1.8%); across all pulse generator, permanent, implantable reports (product code NVZ) death is recorded in 4.1% and malfunction in 43.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are incorrect measurement (13.1%), mechanical problem (11.1%) and pacing problem (9.6%). The patient problems coded most often are hematoma, erosion and bradycardia. 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
No report naming Azure was received in the five years to August 2026; the latest was received in May 2019.
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 95,612 reports carrying product code NVZ. 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 measurementthe device measured wrongly | 120 | 13.1% | 1.6% |
| Mechanical problema mechanical problem | 102 | 11.1% | 3.9% |
| Pacing problem | 88 | 9.6% | 10.5% |
| Unable to obtain readings | 77 | 8.4% | 1.9% |
| Over-sensing | 23 | 2.5% | 5.6% |
| Reset problem | 23 | 2.5% | 1.4% |
| False alarm | 22 | 2.4% | 1.1% |
| Inappropriate or unexpected reset | 21 | 2.3% | 1.9% |
| High impedance | 19 | 2.1% | 1.7% |
| Protective measures problem | 19 | 2.1% | 0.3% |
| Failure to capture | 17 | 1.8% | 3.4% |
| Migration or expulsion of device | 17 | 1.8% | 1.1% |
| Low impedance | 15 | 1.6% | 0.7% |
| Data problem | 14 | 1.5% | 0.8% |
| Impedance problem | 14 | 1.5% | 0.5% |
| Device sensing problem | 13 | 1.4% | 1.4% |
| Output problem | 12 | 1.3% | 0.6% |
| Electromagnetic interference | 11 | 1.2% | 0.9% |
| High capture threshold | 10 | 1.1% | 0.5% |
| Insufficient device problem information | 9 | 1% | 1.8% |
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 |
|---|---|---|
| Hematomaa collection of blood under the skin or in tissue | 25 | 2.7% |
| Erosion | 24 | 2.6% |
| Bradycardiaslow heart rate | 17 | 1.8% |
| Deaththe patient died; cause not stated by this term | 17 | 1.8% |
| Syncopefainting | 17 | 1.8% |
| Dizzinesslight-headedness or unsteadiness | 15 | 1.6% |
| No patient involvement | 15 | 1.6% |
| Complaint, ill-defined | 14 | 1.5% |
| Dyspneashortness of breath | 14 | 1.5% |
| Painpain, site not specified | 11 | 1.2% |
| Pocket erosion | 11 | 1.2% |
| Sepsisa severe body-wide response to infection | 10 | 1.1% |
| Weakness | 8 | 0.9% |
| Palpitationsawareness of the heartbeat | 7 | 0.8% |
| Atrial fibrillationan irregular heart rhythm | 6 | 0.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Azure | Product code NVZ | All MAUDE reports |
|---|---|---|---|
| Reports | 919 | 95,612 | 26,136,888 |
| Share of that pool | — | 1% | 0% |
| Classified as death, per 1,000 reports | 18 | 41 | 9 |
| Classified as injury | 55% | 52.1% | 36.2% |
| Classified as malfunction | 43.2% | 43.5% | 62.3% |
| Filed by the manufacturer | 100% | 98.7% | 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 NVZ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Adapta | 4,893 | 279 | 7.4% |
| Advisa MRI SureScan | 3,589 | 272 | 1.9% |
| Reply | 2,814 | 9 | 1.5% |
| Insignia | 3,792 | 0 | 1.3% |
| Altrua | 4,122 | 0 | 2.4% |
| Carelink | 15,005 | 18 | 0% |
| Sensia IPG | 1,391 | 73 | 2.7% |
| Dextrus 4136 | 5,698 | 0 | 0.8% |
| MyCareLink Patient Monitor | 893 | 47 | 0.1% |
| Pulse Generator Permanent Implantable | 852 | 24 | 1.1% |
| Fortify Vr U1 6 Sj4 Us | 1,564 | 8 | 1.2% |
| Ellipse VR | 1,507 | 45 | 3.7% |
| Symphony | 1,163 | 133 | 1.6% |
| Fortify Assura VR ICD, US | 4,888 | 213 | 2.3% |
| Consulta Crt-P | 680 | 5 | 4.7% |
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 Azure reports
How many FDA reports name Azure?
919 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (55%), malfunction (43.2%) and death (1.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
incorrect measurement (13.1%), mechanical problem (11.1%), pacing problem (9.6%), unable to obtain readings (8.4%) and over-sensing (2.5%). 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 Azure 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.