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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. CAPSUREFIX NOVUS LEAD MRI SURESCAN; PERMANENT PACEMAKER ELECTRODE

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MEDTRONIC, INC. CAPSUREFIX NOVUS LEAD MRI SURESCAN; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 5076
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
A voluntary medwatch form 3500 was received (report #mw5151299 ); since f10 is not contained on that form, select fields in section f have been populated by the manufacturer.  b3: event date is not known.Please see b5 for approximate date range, if applicable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that there was a performance issue on the lead.The lead was capped and replaced. no patient complications have been reported as a result of this event.
 
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Brand Name
CAPSUREFIX NOVUS LEAD MRI SURESCAN
Type of Device
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key18824244
MDR Text Key336734732
Report Number2182208-2024-00845
Device Sequence Number1
Product Code DTB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P930039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/04/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number5076
Device Catalogue Number5076
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/22/2024
Initial Date FDA Received03/04/2024
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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