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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 # mw5152362); 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 submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Event Description
It was reported that the right ventricular (rv) lead exhibited product performance issue.The lead was surgically abandoned.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 Key18976880
MDR Text Key338549832
Report Number2182208-2024-01278
Device Sequence Number1
Product Code DTB
Combination Product (y/n)N
PMA/PMN Number
P930039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2024
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
Date Manufacturer Received03/21/2024
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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