Stimulator, electrical, implantable, for incontinence: medical device reports filed with FDA

83,156 reports carry this product code, 1992–2026; 30 brands with a page.

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.

83,156
reports with this product code: 0.3% of all MAUDE reports; 6,867
reports, 12 months to August 2026: 6,540 in the 12 months before; 50.7%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code EZW is FDA's classification for "Stimulator, electrical, implantable, for incontinence" (gastroenterology, Urology panel), a class 3 device. 83,156 medical device reports carry this product code, 0.3% of the MAUDE database, from March 1992 to August 2026.

6,867 reports arrived in the 12 months to August 2026, close to the 6,540 of 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 (50.7%), injury (48.9%) and other (0.3%). 30 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Interstim	11,249	1,522	0.2%	50.2%
InterStim X	9,332	3,163	0%	55.1%
Verify Enhanced	3,829	295	0%	49.8%
Verify	2,392	8	0%	43.9%
Axonics	2,355	1,069	0.1%	13%
Implantable Neurostimulator	387	692	0.3%	63.6%
Unknown Implantable Neurostimulator	368	0	2.2%	29.3%
Unknown External Neurostimulator	364	0	1.1%	48.1%
External Neurostimulator	283	102	0.4%	52.4%
SureScan	163	490	0%	61.7%
Unknown Neurostimulator	116	0	1.7%	49.6%
Lead	34	118	0.5%	59.7%
Synergy	28	84	3.5%	63.3%
Neu Ins Stimulator	27	0	2.1%	21.5%
Unknown Lead	27	0	2.5%	63.1%
Itrel	17	0	3.4%	29.2%
Enterra	12	0	0.8%	32.3%
Synergy Versitrel	12	4	0%	34.7%
Restore	5	27	0.1%	49.4%
Medtronic	4	17	4.4%	23.5%
Itrel 3	3	10	1.4%	46.8%
Restore Prime	3	2	1.1%	46%
Tbd	3	8	0.6%	72.7%
Primeadvanced	2	16	0%	48.1%
Percept	1	1,239	0.3%	58.6%
Restore Rechargable Neurostimulator	1	0	0.6%	50.1%
Restore Sensor	1	40	0.1%	59%
Restore Ultra	1	39	0.1%	55.7%
Synchromed	1	3	3.2%	35.2%
Unknown Spinal Cord Stimulator	1	0	1.2%	36.7%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Medtronic Puerto Rico Operations	44,212	53.2%
Medtronic Med Rel Medtronic Puerto Rico	16,486	19.8%
Medtronic Neuromodulation	13,918	16.7%
Mdt Puerto Rico Operations Juncos	1,874	2.3%
Axonics Modulation Technologies	1,657	2%
Mdt Puerto Rico Operations	1,065	1.3%
Neuro - Villalba	512	0.6%
Mpri	450	0.5%
Medtronic Puerto Rico Operations Juncos	426	0.5%
Mdt Sofamor Danek Puerto Rico Mfg	262	0.3%
Plexus Manufacturing Sdn Bhd	181	0.2%
Ipg Mfg Switzerland	165	0.2%
Medtronic Europe Sarl	107	0.1%
Rice Creek Mfg	34	0%
Mdt Puerto Rico Operations Med Rel	30	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0.1%80

Injury48.9%40,683

Malfunction50.7%42,169

Other0.3%209

Not given0%15

Who filed

Manufacturer report99.6%82,852

Voluntary report0.3%219

User facility report0%0

Distributor report0%0

Not given0.1%85

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Device operates differently than expectedthe device behaved unexpectedly	14,919	17.9%
Insufficient device problem information	11,566	13.9%
Failure to deliver energy	10,777	13%
Migration or expulsion of device	9,556	11.5%
Inappropriate/inadequate shock/stimulation	7,771	9.3%
Unintended collision	5,271	6.3%
Communication or transmission problemthe device could not communicate or transmit	4,861	5.8%
Breakthe device broke	4,747	5.7%
Energy output problem	4,266	5.1%
High impedance	4,243	5.1%
Electromagnetic compatibility problem	3,969	4.8%
Battery problema problem with the battery	3,963	4.8%
Therapy delivered to incorrect body area	3,751	4.5%
Electromagnetic interference	3,303	4%
Failure to interrogate	3,133	3.8%
Device displays incorrect message	2,697	3.2%
Malposition of device	2,214	2.7%
Intermittent continuity	2,107	2.5%
Patient device interaction problem	1,474	1.8%
Connection problema connection problem	1,259	1.5%

Questions about stimulator, electrical, implantable, for incontinence reports

What is product code EZW?

FDA's classification code for "Stimulator, electrical, implantable, for incontinence", class 3, reviewed by the gastroenterology, Urology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

83,156 reports through August 2026, 6,867 of them in the latest 12 months.

Which brands appear most often?

Interstim (11,249), InterStim X (9,332), Verify Enhanced (3,829), Verify (2,392) and Axonics (2,355). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.