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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI CAPSURE SENSE LEAD MRI SURESCAN; ELECTRODE, PACEMAKER, PERMANENT
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MPRI CAPSURE SENSE LEAD MRI SURESCAN; ELECTRODE, PACEMAKER, PERMANENT Back to Search Results
Model Number 407458
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 06/03/2020
Type of Reportable Event Serious Injury
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 implantable pulse generator (ipg) system was removed due to valve vegetation.The ipg system was replaced approximately twelve days post explant.No further patient complications have been reported as a result of this event.
 
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Brand Name
CAPSURE SENSE LEAD MRI SURESCAN
Common Device Name
ELECTRODE, PACEMAKER, PERMANENT
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key10194969
Report Number2649622-2020-12078
Device Sequence Number19424801
Product Code DTB
UDI-Device Identifier00643169411081
UDI-Public00643169411081
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
P830061
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/25/2020
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 Date01/26/2017
Device Model Number407458
Device Catalogue Number407458
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/03/2020
Initial Report FDA Received Date06/25/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age73 YR
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