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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 5076-85
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); Heart Failure/Congestive Heart Failure (4446)
Date of Event 07/17/2021
Type of Reportable Event Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported by the patients wife that the patient is deceased due to complications of heart failure and a major infection.
 
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Brand Name
CAPSUREFIX NOVUS LEAD MRI SURESCAN
Common Device Name
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key12300901
Report Number2649622-2021-16114
Device Sequence Number19826220
Product Code DTB
UDI-Device Identifier00643169633780
UDI-Public00643169633780
Combination Product (Y/N)Y
Initial Reporter CountryUS
PMA/510(K) Number
P930039
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/10/2021
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 Date03/13/2020
Device Model Number5076-85
Device Catalogue Number5076-85
Was Device Available for Evaluation? No
Type of Report(Section G)Fifteen-Day
Initial Date Received by Manufacturer 07/20/2021
Initial Report FDA Received Date08/10/2021
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
W3DR01 IPG, 5076-65 LEAD
Outcome Attributed to Adverse Event Death;
Patient Age72 YR
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