Devices › Implantable cardioverter defibrillator (non-crt)
Device brand name · Lead
Possis Sutureless Myocardial Lead: medical device reports filed with FDA
244 reports name it, 1993–1997. Manufacturer given most often on reports: Possis Medical. Product code LWS.
- 244
- device reports naming the brand
- 0% of all MAUDE reports · about 7 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 8.6%
- classified as malfunction
- 37.4% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 244 reports that name the brand "Possis Sutureless Myocardial Lead" (lead), received between March 1993 and November 1997; the manufacturer given most often on reports is Possis Medical. Spellings of one product vary from report to report.
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 (90.6%), malfunction (8.6%) and other (0.4%); across all implantable cardioverter defibrillator (non-crt) reports (product code LWS) death is recorded in 2.7% and malfunction in 37.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device damaged prior to use (14.3%), sensing intermittently (5.3%) and inappropriate/inadequate shock/stimulation (4.9%). The patient problems coded most often are surgical procedure, death and other (for use when an appropriate patient code cannot be identified). 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 Possis Sutureless Myocardial Lead was received in the five years to August 2026; the latest was received in November 1997.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 380,959 reports carrying product code LWS. 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 |
|---|---|---|---|
| Device damaged prior to usethe device was damaged before use | 35 | 14.3% | 0.8% |
| Sensing intermittently | 13 | 5.3% | 0.2% |
| Inappropriate/inadequate shock/stimulation | 12 | 4.9% | 12.8% |
| Over-sensing | 10 | 4.1% | 21.1% |
| High impedance | 5 | 2% | 15.6% |
| Normal | 3 | 1.2% | 1.8% |
| Failure to capture | 2 | 0.8% | 2.6% |
| High readingsreadings were too high | 2 | 0.8% | 0% |
| Replace | 2 | 0.8% | 0.4% |
| Device, or device fragments remain in patient | 1 | 0.4% | 0% |
| False device output | 1 | 0.4% | 0% |
| Insulation failure | 1 | 0.4% | 0.1% |
| Invalid sensing | 1 | 0.4% | 0.6% |
| Lead(s), fracture of | 1 | 0.4% | 1.1% |
| Leak/splashthe device leaked | 1 | 0.4% | 0% |
| Low readingsreadings were too low | 1 | 0.4% | 0.2% |
| Material discolored | 1 | 0.4% | 0% |
| Unexpected therapeutic results | 1 | 0.4% | 0.2% |
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 |
|---|---|---|
| Surgical procedure | 4 | 1.6% |
| Deaththe patient died; cause not stated by this term | 1 | 0.4% |
| Other (for use when an appropriate patient code cannot be identified) | 1 | 0.4% |
| Shockshock, a collapse of the circulation | 1 | 0.4% |
| Undesired nerve stimulation | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Possis Sutureless Myocardial Lead | Product code LWS | All MAUDE reports |
|---|---|---|---|
| Reports | 244 | 380,959 | 26,136,888 |
| Share of that pool | — | 0.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 27 | 9 |
| Classified as injury | 90.6% | 59.6% | 36.2% |
| Classified as malfunction | 8.6% | 37.4% | 62.3% |
| Filed by the manufacturer | 0.8% | 97.8% | 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 LWS
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Sprint Quattro Secure S MRI SureScan | 36,895 | 6,436 | 1.4% |
| Emblem Mri S-Icd | 21,480 | 3,088 | 0.2% |
| Sprint Quattro Secure | 24,237 | 2 | 5.2% |
| Emblem S-Icd | 17,250 | 2,237 | 0.1% |
| Sprint Fidelis | 17,005 | 340 | 14.1% |
| Sprint Quattro Secure S | 14,398 | 0 | 2.4% |
| Endotak Reliance | 25,897 | 238 | 1.2% |
| Sprint Quattro Secure MRI SureScan | 15,606 | 1,903 | 1.4% |
| Endotak Reliance G | 10,115 | 1,049 | 0.6% |
| Teligen | 16,537 | 47 | 0.6% |
| Durata Sts Optim Active Fixation | 9,681 | 301 | 5.6% |
| Sprint Quattro | 5,591 | 0 | 2.6% |
| Reliance 4-Front | 9,852 | 2,024 | 0.4% |
| Sprint | 6,131 | 161 | 2.4% |
| Vitality 2 | 4,779 | 0 | 1% |
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 Possis Sutureless Myocardial Lead reports
How many FDA reports name Possis Sutureless Myocardial Lead?
244 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 (90.6%), malfunction (8.6%) and other (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device damaged prior to use (14.3%), sensing intermittently (5.3%), inappropriate/inadequate shock/stimulation (4.9%), over-sensing (4.1%) and high impedance (2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
distributor reports (99.2%) and manufacturer reports (0.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Possis Sutureless Myocardial 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.