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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SINGAPORE OPERATIONS CAPSUREFIX NOVUS MRI SURESCAN; PERMANENT PACEMAKER ELECTRODE
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MEDTRONIC SINGAPORE OPERATIONS CAPSUREFIX NOVUS MRI SURESCAN; PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number 407645
Medical Device Problem Code Low impedance (2285)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/29/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the right atrial (ra) lead exhibited a low lead impedance warning.The ra lead remains in use.No patient complications have been reported as a result of this event.
 
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Brand Name
CAPSUREFIX NOVUS MRI SURESCAN
Common Device Name
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
MEDTRONIC SINGAPORE OPERATIONS
49 changi south avenue 2
nasaco tech centre
singapore 48605 6
SN  486056
MDR Report Key12531550
Report Number3008973940-2021-03505
Device Sequence Number1140743
Product Code DTB
UDI-Device Identifier00763000014636
UDI-Public00763000014636
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P930039
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 09/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date10/16/2019
Device Model Number407645
Device Catalogue Number407645
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/08/2021
Initial Report FDA Received Date09/27/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
407652 LEAD, W4TR01 CRTP, 429888 LEAD
Patient Age85 YR
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