Device manufacturer, as written on reports

Rice Creek Mfg: medical device reports filed with FDA

4,556 reports name it as the manufacturer of the device involved, 2002–2025.

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.

4,556
reports naming it as manufacturer: 0% of all MAUDE reports; 5
reports, 12 months to August 2026: 0 in the 12 months before; 42.6%
classified as malfunction: 62.3% across all reports; 2.3%
classified as death, as reported: 0.9% across all reports

4,556 medical device reports received by FDA give Rice Creek Mfg as the manufacturer of the device involved, 0% of the MAUDE database, from November 2002 to October 2025. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

5 reports arrived in the 12 months to August 2026, with 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 (51.5%), malfunction (42.6%) and other (3.6%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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 named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Synchromed El	Pump, infusion, implanted, programmable	1,597	2	4.9%
Carelink	Programmer, pacemaker	541	18	0%
Indura	Pump, infusion, implanted, programmable	297	0	0.8%
Synchromed	Pump, infusion, implanted, programmable	209	3	3.2%
Capsure EPI	Permanent pacemaker electrode	121	0	7%
Capsureepi	Permanent pacemaker electrode	75	0	2.4%
CapSure Epicardial Lead	Permanent pacemaker electrode	59	760	1.5%
Medtronic Lead	Implantable pacemaker pulse-generator	52	328	9.5%
Indura Catheter	Pump, infusion, implanted, programmable	43	0	0%
Capsurefix Novus	Permanent pacemaker electrode	39	4	6.8%
Sprint	Implantable cardioverter defibrillator (non-crt)	38	161	2.4%
TYRX Absorbable Antibacterial Envelope	Mesh, surgical, polymeric	37	126	1.6%
Sprint Quattro	Implantable cardioverter defibrillator (non-crt)	29	0	2.6%
Capsure Sense	Permanent pacemaker electrode	26	0	6.4%
Implantable Neurostimulator	Stimulator, spinal-cord, totally implanted for pain relief	26	692	0.3%
Carelink Program W/Telemetry C	Implantable pacemaker pulse-generator	25	0	0%
Attain Ability	Drug eluting permanent left ventricular (lv) pacemaker electrode	24	0	4.4%
Transvene	Implantable cardioverter defibrillator (non-crt)	24	0	2%
Attain	Permanent pacemaker electrode	23	0	1.5%
Tbd	Catheter and tip, suction	21	8	0.6%
Intrathecal Catheter	Pump, infusion, implanted, programmable	16	18	0.1%
Sprint Quattro Secure	Implantable cardioverter defibrillator (non-crt)	15	2	5.2%
Verify Enhanced	Stimulator, electrical, implantable, for incontinence	15	295	0%
Capsure Z Novus	Permanent pacemaker electrode	14	0	5.9%
Capsurefix	Permanent pacemaker electrode	13	0	6.3%
CapSure SP	Permanent pacemaker electrode	12	226	3.9%
Interstim	Stimulator, electrical, implantable, for incontinence	12	1,522	0.2%
Activa	Stimulator, electrical, implanted, for parkinsonian tremor	11	1,112	0.6%
CapSure	Permanent pacemaker electrode	11	51	4.8%
Sprint Fidelis	Implantable cardioverter defibrillator (non-crt)	11	340	14.1%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
LKK	Pump, infusion, implanted, programmable	2,211	48.5%
DXY	Implantable pacemaker pulse-generator	976	21.4%
DTB	Permanent pacemaker electrode	358	7.9%
LWS	Implantable cardioverter defibrillator (non-crt)	192	4.2%
LWP	Implantable pulse generator, pacemaker (non-crt)	181	4%
NVN	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	159	3.5%
NVZ	Pulse generator, permanent, implantable	77	1.7%
OJX	Drug eluting permanent left ventricular (lv) pacemaker electrode	69	1.5%
KRG	Programmer, pacemaker	60	1.3%
FTL	Mesh, surgical, polymeric	42	0.9%

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

Death2.3%106

Injury51.5%2,345

Malfunction42.6%1,939

Other3.6%164

Not given0%2

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Rice Creek Mfg reports

How many FDA device reports name Rice Creek Mfg as manufacturer?

4,556 reports through August 2026, 5 of them in the latest 12 months.

Which of its brands appear most often?

Synchromed El (1,597), Carelink (541), Indura (297), Synchromed (209) and Capsure EPI (121).

Which device types does it report on?

pump, infusion, implanted, programmable (48.5%), implantable pacemaker pulse-generator (21.4%), permanent pacemaker electrode (7.9%) and implantable cardioverter defibrillator (non-crt) (4.2%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.