Contak Renewal 2 Is-1/Df-1/Lv-1 - Clinical Device Will Not Be Marketed: medical device reports filed with FDA

204 reports name it, 2009–2010. Manufacturer given most often on reports: Guidant Crm Clonmel Ireland. Product code NIK.

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.

204
device reports naming the brand: 0% of all MAUDE reports · about 12 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 74.5%
classified as malfunction: 47.2% across the product code; 0.5%
classified as death, as reported: 1 reports · not verified by FDA

204 medical device reports received by FDA name the brand "Contak Renewal 2 Is-1/Df-1/Lv-1 - Clinical Device Will Not Be Marketed" (implantable chf generator); the manufacturer given most often on reports is Guidant Crm Clonmel Ireland; received from February 2009 to May 2010. 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 malfunction (74.5%), injury (25%) and death (0.5%); across all defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) reports (product code NIK) death is recorded in 2.8% and malfunction in 47.2%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are low battery (41.2%), normal (36.3%) and insufficient device problem information (13.7%). The patient problems coded most often are other (for use when an appropriate patient code cannot be identified) and death. 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 Contak Renewal 2 Is-1/Df-1/Lv-1 - Clinical Device Will Not Be Marketed was received in the five years to August 2026; the latest was received in May 2010.

Event type and report source

Event type, as classified on the report

Death0.5%1

Injury25%51

Malfunction74.5%152

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%204

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 170,404 reports carrying product code NIK. 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
Low battery	84	41.2%	2.4%
Normal	74	36.3%	0.8%
Insufficient device problem information	28	13.7%	1.3%
Premature discharge of battery	16	7.8%	11%
Alarm, error of warning	7	3.4%	0.2%
Malfunction	4	2%	0.4%
Device operates differently than expectedthe device behaved unexpectedly	2	1%	1.5%
Device sensing problem	1	0.5%	2.6%
Difficult to interrogate	1	0.5%	0.2%
High impedance	1	0.5%	5.6%
Mechanical problema mechanical problem	1	0.5%	1.4%
Noise	1	0.5%	0.5%
Over-sensing	1	0.5%	22.3%
Pacing problem	1	0.5%	4.9%

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)	3	1.5%
Deaththe patient died; cause not stated by this term	1	0.5%

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

In context

Measure	Contak Renewal 2 Is-1/Df-1/Lv-1 - Clinical Device Will Not Be Marketed	Product code NIK	All MAUDE reports
Reports	204	170,404	26,136,888
Share of that pool	—	0.1%	0%
Classified as death, per 1,000 reports	5	28	9
Classified as injury	25%	49.8%	36.2%
Classified as malfunction	74.5%	47.2%	62.3%
Filed by the manufacturer	100%	99.2%	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 NIK

Brand	Reports	Latest 12 months	Classified as death
Quadra Assura MP ICD	14,897	507	2.1%
Gallant HF	8,971	1,918	0.7%
Quadra Assura Crt-D Quad Rf Hv	7,971	14	2.5%
Quartet	14,149	848	5.2%
Unify Assura CRT-D RF HV	6,731	186	3.7%
Unify Crt-D	5,907	10	3.4%
Consulta Crt-D	4,623	0	5.9%
Unify Assura ICD	4,511	127	1.6%
Claria MRI Quad CRT-D SureScan	3,775	274	2.2%
Cognis	8,694	6	1.5%
Protecta Xt Crt-D	3,541	3	4.5%
Quadra Assura Ddqp+	3,349	0	2.3%
Contak Renewal	3,745	0	4.8%
Cobalt XT HF Quad CRT-D MRI SureScan	2,581	791	3%
Quadra Assura ICD	2,526	67	0.8%

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 Contak Renewal 2 Is-1/Df-1/Lv-1 - Clinical Device Will Not Be Marketed reports

How many FDA reports name Contak Renewal 2 Is-1/Df-1/Lv-1 - Clinical Device Will Not Be Marketed?

204 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?

malfunction (74.5%), injury (25%) and death (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

low battery (41.2%), normal (36.3%), insufficient device problem information (13.7%), premature discharge of battery (7.8%) and alarm, error of warning (3.4%). 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 Contak Renewal 2 Is-1/Df-1/Lv-1 - Clinical Device Will Not Be Marketed 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.