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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI CAPSUREFIX NOVUS LEAD MRI SURESCAN; ELECTRODE, PACEMAKER, PERMANENT
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MPRI CAPSUREFIX NOVUS LEAD MRI SURESCAN; ELECTRODE, PACEMAKER, PERMANENT Back to Search Results
Model Number 5076-35
Medical Device Problem Code Over-Sensing (1438)
Health Effect - Clinical Codes Syncope (1610); Palpitations (2467)
Date of Event 02/05/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: w1dr01 ipg, implanted: (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the patient experienced syncope and palpitations.It was further reported that the right atrial (ra) lead exhibited over-sensing of far field r-waves (ffrw).The ra lead was explanted and replaced.No further patient complications have been reported as a result of this event.
 
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Brand Name
CAPSUREFIX NOVUS LEAD MRI SURESCAN
Common Device Name
ELECTRODE, PACEMAKER, PERMANENT
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key9778833
Report Number2649622-2020-04330
Device Sequence Number14115872
Product Code DTB
UDI-Device Identifier00681490729963
UDI-Public00681490729963
Combination Product (Y/N)N
Initial Reporter StateMD
Initial Reporter CountryUS
PMA/510(K) Number
P930039
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2005
Device Explanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/03/2020
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? Yes
Operator of Device Lay User/Patient
Device Expiration Date03/31/2007
Device Model Number5076-35
Device Catalogue Number5076-35
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/05/2020
Initial Report FDA Received Date03/03/2020
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
407645 LEAD
Outcome Attributed to Adverse Event Hospitalization; Life Threatening; Required Intervention;
Patient Age60 YR
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