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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI CAPSUREFIX NOVUS MRI SURESCAN; ELECTRODE, PACEMAKER, PERMANENT
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MPRI CAPSUREFIX NOVUS MRI SURESCAN; ELECTRODE, PACEMAKER, PERMANENT Back to Search Results
Model Number 407685
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 09/14/2012
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 5568-45, lead, implanted: (b)(6) 1997; 1058t, lead, implanted: (b)(6) 2007.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the cardiac resynchronization therapy pacemaker (crt-p) system was explanted due to an infection.A replacement system was implanted a few days later.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)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key10967975
Report Number2649622-2020-23876
Device Sequence Number960797
Product Code DTB
UDI-Device Identifier00613994329400
UDI-Public00613994329400
Combination Product (Y/N)Y
PMA/510(K) Number
P930039
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Device Explanted Year2012
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/08/2020
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 Date03/23/2014
Device Model Number407685
Device Catalogue Number407685
Was Device Available for Evaluation? No
Type of Report(Section G)Fifteen-Day
Initial Date Received by Manufacturer 11/11/2020
Initial Report FDA Received Date12/08/2020
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
C4TR01 CRTP
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age54 YR
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