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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SINGAPORE OPERATIONS CAPSUREFIX NOVUS MRI SURESCAN; ELECTRODE, PACEMAKER, PERMANENT
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MEDTRONIC SINGAPORE OPERATIONS CAPSUREFIX NOVUS MRI SURESCAN; ELECTRODE, PACEMAKER, PERMANENT Back to Search Results
Model Number 407658
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 03/10/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 4557m-53 lead, implanted: (b)(6) 1992.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the patient experienced an infection.The implantable pulse generator (ipg) system was explanted and replaced with a leadless ipg.No further patient complications have been reported as a result of this event.
 
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Brand Name
CAPSUREFIX NOVUS MRI SURESCAN
Common Device Name
ELECTRODE, PACEMAKER, PERMANENT
Manufacturer (Section D)
MEDTRONIC SINGAPORE OPERATIONS
49 changi south avenue 2
nasaco tech centre
singapore 48605 6
SG  486056
MDR Report Key9915270
Report Number3008973940-2020-00793
Device Sequence Number2496782
Product Code DTB
UDI-Device Identifier00763000014650
UDI-Public00763000014650
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
P930039
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/02/2020
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? No
Operator of Device Lay User/Patient
Device Expiration Date10/05/2019
Device Model Number407658
Device Catalogue Number407658
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/10/2020
Initial Report FDA Received Date04/02/2020
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
ADDR01 IPG
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age85 YR
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