Dorsal root ganglion stimulator for pain relief: medical device reports filed with FDA

19,915 reports carry this product code, 2016–2026; 21 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.

19,915
reports with this product code: 0.1% of all MAUDE reports; 1,921
reports, 12 months to August 2026: 2,102 in the 12 months before; 1.2%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

Product code PMP is FDA's classification for "Dorsal root ganglion stimulator for pain relief" (unknown panel), a class 3 device. 19,915 medical device reports carry this product code, 0.1% of the MAUDE database, from May 2016 to August 2026.

1,921 reports arrived in the 12 months to August 2026, close to the 2,102 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 injury (98.6%), malfunction (1.2%) and death (0.2%). 21 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
Kit Implantable Slim Tip Lead, 50cm	9,953	1,417	0.1%	0.4%
50cm Implant Lead Kit Slim Tip	2,695	0	0.1%	0.7%
Proclaim DRG Implantable Pulse Generator	1,923	307	0.3%	4.7%
Kit Implantable Slim Tip Lead, 90cm	1,425	119	0.3%	0.5%
90cm Implant Lead Kit Slim Tip	694	0	0.7%	0.1%
Implantable Neurostimulator Kit	421	0	0%	1.4%
50cm Trial Lead Kit Slim Tip	328	0	0.6%	0.3%
Kit Trial Slim Tip Lead 50cm	251	17	2%	0.4%
Proclaim Drg Ipg	160	0	0.6%	15.7%
Axium	41	14	13.1%	29.6%
Implantable Neurostimulator	20	692	0.3%	63.6%
Infinity 7 Implantable Pulse Generator	4	147	0.5%	2.5%
SCS Lead	4	29	0%	3.7%
Lead	3	118	0.5%	59.7%
Proclaim 5 Elite Implantable Pulse Generator	3	2,057	0.1%	6.5%
Cardiomems Patient Electronic System	2	738	0%	98.4%
Infinity 5 Implantable Pulse Generator	2	22	0.6%	3.1%
Octrode Lead Kit, 60cm Length	2	5,133	0.1%	0.8%
Guardian Cranial Burr Hole Cover System	1	30	0%	0%
Octrode Lead	1	45	0%	15.6%
Octrode Trial Lead Kit, 60cm Length	1	71	1.4%	2.6%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Abbott Medical	12,105	60.8%
St Jude Medical - Neuromodulation	6,122	30.7%
St Jude Medical - Spinal Modulation	1,626	8.2%
St Jude Medical - Neuromodulation Puerto Rico	19	0.1%
St Jude Medical - Cardiomems	2	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

Death0.2%32

Injury98.6%19,632

Malfunction1.2%245

Other0%6

Not given0%0

Who filed

Manufacturer report99.7%19,864

Voluntary report0.2%45

User facility report0%0

Distributor report0%0

Not given0%6

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

Device problems coded

Device problem (FDA code)	Reports	Share
Migrationthe device moved from where it was placed	4,631	23.3%
High impedance	2,703	13.6%
Therapeutic or diagnostic output failure	2,329	11.7%
Fracturea broken bone	1,931	9.7%
Impedance problem	447	2.2%
Insufficient device problem information	411	2.1%
Material fragmentation	379	1.9%
Wireless communication problema wireless connection problem	336	1.7%
Battery problema problem with the battery	246	1.2%
Disconnection	176	0.9%
Low impedance	176	0.9%
Inappropriate/inadequate shock/stimulation	150	0.8%
Patient-device incompatibilitythe device did not suit the patient	123	0.6%
Failure to deliver energy	78	0.4%
Breakthe device broke	72	0.4%
Premature elective replacement indicator	59	0.3%
Improper or incorrect procedure or method	46	0.2%
No device output	45	0.2%
Migration or expulsion of device	36	0.2%
Therapy delivered to incorrect body area	35	0.2%

Questions about dorsal root ganglion stimulator for pain relief reports

What is product code PMP?

FDA's classification code for "Dorsal root ganglion stimulator for pain relief", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

19,915 reports through August 2026, 1,921 of them in the latest 12 months.

Which brands appear most often?

Kit Implantable Slim Tip Lead, 50cm (9,953), 50cm Implant Lead Kit Slim Tip (2,695), Proclaim DRG Implantable Pulse Generator (1,923), Kit Implantable Slim Tip Lead, 90cm (1,425) and 90cm Implant Lead Kit Slim Tip (694). 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.