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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 Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Pocket Erosion (2013)
Date of Event 03/28/2020
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 patient had pocket erosion at the implant site of their implantable cardioverter defibrillator (icd).The icd and subsequent leads have been extracted.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 Key9933880
Report Number2649622-2020-07187
Device Sequence Number690074
Product Code DTB
UDI-Device Identifier00643169550742
UDI-Public00643169550742
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
P930039
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/07/2020
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 Date07/14/2018
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 03/28/2020
Initial Report FDA Received Date04/08/2020
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
5076-35, LEAD / 6947M55, LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age85 YR
Patient Weight63
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