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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI CAPSURE SP NOVUS LEAD; ELECTRODE, PACEMAKER, PERMANENT
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MPRI CAPSURE SP NOVUS LEAD; ELECTRODE, PACEMAKER, PERMANENT Back to Search Results
Model Number 5592-53
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 06/24/2019
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 patient experienced an infection.The implantable pulse generator (ipg) was explanted.It was also reported that the right atrial (ra) lead and right ventricular (rv) lead were explanted due to infection and the pacing system replaced with a leadless pacemaker.No further patient complications have been reported as a result of this event.
 
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Brand Name
CAPSURE SP NOVUS LEAD
Common Device Name
ELECTRODE, PACEMAKER, PERMANENT
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key8910665
Report Number2649622-2019-14730
Device Sequence Number11164447
Product Code DTB
UDI-Device Identifier00643169590731
UDI-Public00643169590731
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
P850089
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/20/2019
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 Date07/18/2018
Device Model Number5592-53
Device Catalogue Number5592-53
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/14/2019
Initial Report FDA Received Date08/20/2019
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
A2DR01 IPG, 4076-58 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age82 YR
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