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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI CAPSUREFIX NOVUS LEAD MRI SURESCAN; ELECTRODE, PACEMAKER, PERMANENT
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MPRI CAPSUREFIX NOVUS LEAD MRI SURESCAN; ELECTRODE, PACEMAKER, PERMANENT Back to Search Results
Model Number 5076-85
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 05/22/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: cd2357-40c icd, implanted: (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the patient experienced a pocket infection.The right atrial (ra) lead was noted to be tunneled from right.The ra lead was adjusted and remains in use.No further patient complications have been reported as a result of this event.
 
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Brand Name
CAPSUREFIX NOVUS LEAD MRI SURESCAN
Common Device Name
ELECTRODE, PACEMAKER, PERMANENT
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key9659137
Report Number2649622-2020-02569
Device Sequence Number19670647
Product Code DTB
UDI-Device Identifier00681490730099
UDI-Public00681490730099
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 Year2014
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/03/2020
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 Date01/16/2015
Device Model Number5076-85
Device Catalogue Number5076-85
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/08/2020
Initial Report FDA Received Date02/03/2020
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
1581 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age88 YR
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