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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 5076-65
Medical Device Problem Codes Signal Artifact/Noise (1036); High Capture Threshold (3266)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/21/2019
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 right ventricular (rv) lead exhibited high thresholds and noise.The lead was explanted and replaced.No 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 Key8703061
Report Number2649622-2019-10293
Device Sequence Number11359405
Product Code DTB
UDI-Device Identifier00643169448919
UDI-Public00643169448919
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
P930039
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/17/2019
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? Yes
Operator of Device Lay User/Patient
Device Expiration Date06/04/2017
Device Model Number5076-65
Device Catalogue Number5076-65
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/21/2019
Initial Report FDA Received Date06/17/2019
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
ADDR01 IPG, 5076-52 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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