Devices › Appliance, fixation, spinal intervertebral body
Device brand name · Implantable cardioverter defibrillator
Resonate: medical device reports filed with FDA
227 reports name it, 2017–2026. Manufacturer given most often on reports: Globus Medical. Product code KWQ.
- 227
- device reports naming the brand
- 0% of all MAUDE reports · about 26 a year
- 7
- reports, 12 months to August 2026
- 20 in the 12 months before
- 69.6%
- classified as malfunction
- 42.4% across the product code
- 0.9%
- classified as death, as reported
- 2 reports · not verified by FDA
227 medical device reports received by FDA name the brand "Resonate" (implantable cardioverter defibrillator); the manufacturer given most often on reports is Globus Medical; received from October 2017 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
7 reports arrived in the 12 months to August 2026, down 65% from 20 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 malfunction (69.6%), injury (29.5%) and death (0.9%); across all appliance, fixation, spinal intervertebral body reports (product code KWQ) death is recorded in 0.6% and malfunction in 42.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are migration (12.8%), device slipped (11.5%) and device dislodged or dislocated (10.1%). The patient problems coded most often are failure of implant, sepsis and spinal column injury. 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 10,584 reports carrying product code KWQ. 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 |
|---|---|---|---|
| Migrationthe device moved from where it was placed | 29 | 12.8% | 4.7% |
| Device slipped | 26 | 11.5% | 4.1% |
| Device dislodged or dislocated | 23 | 10.1% | 5.4% |
| Ambient noise problem | 13 | 5.7% | 0% |
| High impedance | 13 | 5.7% | 0% |
| Over-sensing | 9 | 4% | 0% |
| Fracturea broken bone | 8 | 3.5% | 8.4% |
| Breakthe device broke | 7 | 3.1% | 20.8% |
| Pacing problem | 7 | 3.1% | 0% |
| Defective devicethe device was defective | 6 | 2.6% | 0.1% |
| Capturing problem | 5 | 2.2% | 0% |
| Detachment of device or device componentpart of the device came off | 5 | 2.2% | 1.8% |
| Failure to capture | 5 | 2.2% | 0% |
| Inappropriate/inadequate shock/stimulation | 5 | 2.2% | 0% |
| Loose or intermittent connection | 5 | 2.2% | 1.3% |
| Human-device interface problem | 4 | 1.8% | 0.1% |
| Loosening of implant not related to bone-ingrowth | 4 | 1.8% | 0.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 3 | 1.3% | 2.6% |
| Device sensing problem | 3 | 1.3% | 0% |
| Communication or transmission problemthe device could not communicate or transmit | 2 | 0.9% | 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 |
|---|---|---|
| Failure of implant | 19 | 8.4% |
| Sepsisa severe body-wide response to infection | 9 | 4% |
| Spinal column injury | 7 | 3.1% |
| Hematomaa collection of blood under the skin or in tissue | 5 | 2.2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 4 | 1.8% |
| Twiddlers syndrome | 4 | 1.8% |
| No patient involvement | 3 | 1.3% |
| Painpain, site not specified | 3 | 1.3% |
| Pocket erosion | 3 | 1.3% |
| Complaint, ill-defined | 2 | 0.9% |
| Deaththe patient died; cause not stated by this term | 2 | 0.9% |
| Post operative wound infection | 2 | 0.9% |
| Staphylococcus aureus | 2 | 0.9% |
| Atrial fibrillationan irregular heart rhythm | 1 | 0.4% |
| Atrial tachycardia | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Resonate | Product code KWQ | All MAUDE reports |
|---|---|---|---|
| Reports | 227 | 10,584 | 26,136,888 |
| Share of that pool | — | 2.1% | 0% |
| Classified as death, per 1,000 reports | 9 | 6 | 9 |
| Classified as injury | 29.5% | 54.1% | 36.2% |
| Classified as malfunction | 69.6% | 42.4% | 62.3% |
| Filed by the manufacturer | 99.6% | 95% | 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 KWQ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| ATLANTIS Anterior Cervical Plate System | 565 | 18 | 1.6% |
| CD HORIZON Spinal System | 9,787 | 634 | 0.3% |
| Venture Anterior Cervical Plate System | 209 | 4 | 0.5% |
| Zevo Anterior Cervical Plate System | 157 | 13 | 0.6% |
| Collect No Qas Spine Anterior Stabilis | 269 | 0 | 0% |
| Unknown K2m Product | 269 | 37 | 0% |
| Tsrh Spinal Fixation System | 154 | 0 | 0% |
| Unknown_Spine_Product | 596 | 24 | 0% |
| Synthes | 470 | 0 | 0.6% |
| Incompass | 170 | 0 | 0% |
| Tsrh Spinal System | 457 | 0 | 0.4% |
| Pivox Oblique Lateral Spinal System | 255 | 5 | 0% |
| Stardrive Screwdriver Shaft T8 105mm | 329 | 43 | 0% |
| Screw | 647 | 0 | 0% |
| Vertex Reconstruction System | 759 | 9 | 0.3% |
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 Resonate reports
How many FDA reports name Resonate?
227 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 7 in the latest 12 months.
What kinds of events are reported?
malfunction (69.6%), injury (29.5%) and death (0.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
migration (12.8%), device slipped (11.5%), device dislodged or dislocated (10.1%), ambient noise problem (5.7%) and high impedance (5.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Resonate 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.