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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI CAPSUREFIX NOVUS; ELECTRODE, PACEMAKER, PERMANENT
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MPRI CAPSUREFIX NOVUS; ELECTRODE, PACEMAKER, PERMANENT Back to Search Results
Model Number 5076-35
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/24/2018
Type of Reportable Event Malfunction
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 right atrial lead showed undersensing.The lead remains in use.No patient complications have been reported as a result of this event.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
CAPSUREFIX NOVUS
Common Device Name
ELECTRODE, PACEMAKER, PERMANENT
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key7738746
Report Number2649622-2018-12496
Device Sequence Number19092642
Product Code DTB
UDI-Device Identifier00643169633735
UDI-Public00643169633735
Combination Product (Y/N)N
Initial Reporter StateDE
Initial Reporter CountryUS
PMA/510(K) Number
P930039
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date03/20/2020
Device Model Number5076-35
Device Catalogue Number5076-35
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/24/2018
Supplement Date Received by Manufacturer08/08/2018
Initial Report FDA Received Date08/01/2018
Supplement Report FDA Received Date10/03/2018
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
W1DR01 IPG, 5076-45 LEAD
Patient Age76 YR
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