Devices › Pacemaker/icd/crt non-implanted components
Device brand name · Pacemaker/icd/crt non-implanted components
Smartview: medical device reports filed with FDA
317 reports name it, 2014–2025. Manufacturer given most often on reports: Sorin Group Italia - Crm Facility. Product code OSR.
- 317
- device reports naming the brand
- 0% of all MAUDE reports · about 26 a year
- 5
- reports, 12 months to August 2026
- 10 in the 12 months before
- 99.7%
- classified as malfunction
- 99.8% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 317 reports that name the brand "Smartview" (pacemaker/icd/crt non-implanted components), received between March 2014 and December 2025; the manufacturer given most often on reports is Sorin Group Italia - Crm Facility. Spellings of one product vary from report to report.
5 reports arrived in the 12 months to August 2026, down 50% from 10 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 (99.7%) and injury (0.3%); across all pacemaker/icd/crt non-implanted components reports (product code OSR) death is recorded in 0% and malfunction in 99.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are communication or transmission problem (23.3%), wireless communication problem (16.1%) and device operates differently than expected (13.2%). The patient problems coded most often are no patient involvement, appropriate clinical signs, symptoms and conditions term/code not available and shock. 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 58,914 reports carrying product code OSR. 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 |
|---|---|---|---|
| Communication or transmission problemthe device could not communicate or transmit | 74 | 23.3% | 2.2% |
| Wireless communication problema wireless connection problem | 51 | 16.1% | 0.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 42 | 13.2% | 0.1% |
| Data problem | 21 | 6.6% | 0.3% |
| Failure to power up | 16 | 5% | 0.1% |
| Defective component | 15 | 4.7% | 0.1% |
| Failure to transmit record | 9 | 2.8% | 0% |
| Connection problema connection problem | 8 | 2.5% | 0.1% |
| Detachment of device or device componentpart of the device came off | 8 | 2.5% | 0% |
| Device operational issue | 6 | 1.9% | 0% |
| No device output | 6 | 1.9% | 0% |
| Device packaging compromised | 5 | 1.6% | 0% |
| Activation problem | 4 | 1.3% | 0% |
| Application program freezes or fails to launch | 4 | 1.3% | 0.2% |
| Computer software problema software problem | 3 | 0.9% | 69.3% |
| Defective devicethe device was defective | 3 | 0.9% | 1.3% |
| Power problem | 3 | 0.9% | 0.2% |
| Application program problem | 2 | 0.6% | 0.3% |
| Component missing | 2 | 0.6% | 0% |
| Date/time-related software problem | 2 | 0.6% | 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 |
|---|---|---|
| No patient involvement | 9 | 2.8% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0.3% |
| Shockshock, a collapse of the circulation | 1 | 0.3% |
| Sleep dysfunction | 1 | 0.3% |
| Syncopefainting | 1 | 0.3% |
| Tachycardiafast heart rate | 1 | 0.3% |
| Twiddlers syndrome | 1 | 0.3% |
| Ventricular fibrillationa chaotic rhythm from the lower heart chambers | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Smartview | Product code OSR | All MAUDE reports |
|---|---|---|---|
| Reports | 317 | 58,914 | 26,136,888 |
| Share of that pool | — | 0.5% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 0.3% | 0.2% | 36.2% |
| Classified as malfunction | 99.7% | 99.8% | 62.3% |
| Filed by the manufacturer | 100% | 100% | 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 OSR
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| CareLink SmartSync Common App iOS | 56,799 | 55,695 | 0% |
| LATITUDE Programming System | 1,323 | 108 | 0% |
| CareLink SmartSync Base | 1,864 | 227 | 0% |
| Smart Monitor | 262 | 32 | 0% |
| LATITUDE Communicator | 338 | 60 | 0% |
| Patient Connector | 207 | 83 | 0% |
| Communicator | 259 | 0 | 0% |
| Carelink Encore | 368 | 0 | 0% |
| SmartTouch | 668 | 132 | 0% |
| Autogen | 2,192 | 212 | 1% |
| Merlin Net / Hf Portal | 259 | 34 | 0% |
| MyCareLink Patient Monitor | 893 | 47 | 0.1% |
| Screwdriver | 396 | 15 | 0% |
| Altrua 60 | 971 | 29 | 0.6% |
| Carelink Smartsync Platform Ios | 870 | 1 | 0% |
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 Smartview reports
How many FDA reports name Smartview?
317 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 5 in the latest 12 months.
What kinds of events are reported?
malfunction (99.7%) and injury (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
communication or transmission problem (23.3%), wireless communication problem (16.1%), device operates differently than expected (13.2%), data problem (6.6%) and failure to power up (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 Smartview 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.