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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI CAPSUREFIX NOVUS LEAD MRI SURESCAN; PERMANENT PACEMAKER ELECTRODE
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MPRI CAPSUREFIX NOVUS LEAD MRI SURESCAN; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 5076-45
Device Problems Failure to Capture (1081); Capturing Problem (2891); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
Patient Problems Chest Pain (1776); Syncope/Fainting (4411); Twiddlers Syndrome (4563)
Event Date 01/01/2024
Event Type  Injury  
Manufacturer Narrative
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 patient had chest pain and syncope.It was found that the right atrial (ra) lead had increasing thresholds that became high, and right atrial (ra) lead capture could not be confirmed.Additionally, it was noted that the right ventricular (rv) lead has had chronic low r-waves.The leads remain in use.No further patient complications have been reported as a result of this event.
 
Event Description
It was further reported that the ra and rv leads were explanted.
 
Manufacturer Narrative
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 further reported that post original implant, the patient had experienced itching at the device pocket and manipulated/twisted the device under their skin, which caused dislodgement of the ra and rv leads.
 
Manufacturer Narrative
Product event summary: the full lead was returned and analyzed.No anomalies were found.The distal low voltage electrode of the lead was covered in body tissue/fibrotic growth.Visual analysis of the lead indicated apparent explant damage.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.
 
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Brand Name
CAPSUREFIX NOVUS LEAD MRI SURESCAN
Type of Device
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
Manufacturer (Section G)
MPRI
road 149 km 56.3
villalba PR 00766
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key19133993
MDR Text Key340496277
Report Number2649622-2024-10761
Device Sequence Number1
Product Code DTB
UDI-Device Identifier00643169633742
UDI-Public00643169633742
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 Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 05/14/2024
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 Number5076-45
Device Catalogue Number5076-45
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/01/2024
Initial Date FDA Received04/18/2024
Supplement Dates Manufacturer Received04/15/2024
04/30/2024
Supplement Dates FDA Received04/30/2024
05/14/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/05/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
DDPA2D4 ICD, 6935M55 LEAD
Patient Outcome(s) Required Intervention; Life Threatening; Hospitalization;
Patient Age35 YR
Patient SexFemale
Patient Weight66 KG
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