Sweet Tip Bipolar Lead: medical device reports filed with FDA

254 reports name it, 1997–1997. Manufacturer given most often on reports: Cardiac Pacemakers. Product code DXY.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

254
device reports naming the brand: 0% of all MAUDE reports · about 9 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 16.1%
classified as malfunction: 41.2% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

254 medical device reports received by FDA name the brand "Sweet Tip Bipolar Lead" (bipolar lead); the manufacturer given most often on reports is Cardiac Pacemakers; received from January 1997 to November 1997. 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 (83.9%) and malfunction (16.1%); across all implantable pacemaker pulse-generator reports (product code DXY) death is recorded in 3.4% and malfunction in 41.2%. 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 (41.3%), dislodged (24%) and normal (13.4%). The patient problems coded most often are other (for use when an appropriate patient code cannot be identified), pocket erosion and surgical procedure, repeated. 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 Sweet Tip Bipolar Lead was received in the five years to August 2026; the latest was received in November 1997.

Event type and report source

Event type, as classified on the report

Death0%0

Injury83.9%213

Malfunction16.1%41

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%254

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 57,832 reports carrying product code DXY. 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	105	41.3%	0.6%
Dislodged	61	24%	0.2%
Normal	34	13.4%	2%
Failure to capture	26	10.2%	6.3%
Loss of threshold	19	7.5%	0.6%
High impedance	17	6.7%	3.8%
Over-sensing	15	5.9%	5.4%
Sensing intermittently	12	4.7%	0.7%
Difficult to position	11	4.3%	0%
Material erosion	5	2%	0.9%
Performance	5	2%	0.4%
Under-sensing	4	1.6%	1.4%
Unexpected therapeutic results	4	1.6%	0.1%
Inappropriate/inadequate shock/stimulation	3	1.2%	0.8%
Contamination	2	0.8%	0.1%
Low readingsreadings were too low	2	0.8%	0.1%
Pacing problem	2	0.8%	6.4%

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
Other (for use when an appropriate patient code cannot be identified)	10	3.9%
Pocket erosion	4	1.6%
Surgical procedure, repeated	3	1.2%
Twiddlers syndrome	2	0.8%
Bradycardiaslow heart rate	1	0.4%
Deaththe patient died; cause not stated by this term	1	0.4%
Hematomaa collection of blood under the skin or in tissue	1	0.4%
Perforation	1	0.4%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Sweet Tip Bipolar Lead	Product code DXY	All MAUDE reports
Reports	254	57,832	26,136,888
Share of that pool	—	0.4%	0%
Classified as death, per 1,000 reports	0	34	9
Classified as injury	83.9%	54.4%	36.2%
Classified as malfunction	16.1%	41.2%	62.3%
Filed by the manufacturer	100%	96.6%	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 DXY

Brand	Reports	Latest 12 months	Classified as death
Tendril Mri	7,076	422	4.1%
Medtronic Lead	2,351	328	9.5%
Carelink Program W/Telemetry C	1,681	0	0%
Carelink	15,005	18	0%
Assurity Mri	18,995	2,035	1.8%
Insignia Plus	940	0	9.1%
Insignia Ultra	797	0	5.4%
Meta Dddr	532	0	0.4%
Enpulse	606	3	10.4%
Medtronic ICD	404	105	23.8%
Insignia Entra	374	0	10.2%
Anthem Rf	372	0	4.3%
Tempo	721	155	0.7%
Medtronic	2,953	17	4.4%
Symphony	1,163	133	1.6%

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 Sweet Tip Bipolar Lead reports

How many FDA reports name Sweet Tip Bipolar Lead?

254 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 (83.9%) and malfunction (16.1%). "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 (41.3%), dislodged (24%), normal (13.4%), failure to capture (10.2%) and loss of threshold (7.5%). 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 Sweet Tip Bipolar 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.