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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI CAPSURE SENSE LEAD MRI SURESCAN; ELECTRODE, PACEMAKER, PERMANENT
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MPRI CAPSURE SENSE LEAD MRI SURESCAN; ELECTRODE, PACEMAKER, PERMANENT Back to Search Results
Model Number 407452
Medical Device Problem Code Over-Sensing (1438)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/28/2020
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 ventricular (rv) lead exhibited intermittent oversensing on stored electrograms (egm).The rv lead re mains in use.No patient complications have been reported as a result of this event.
 
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Brand Name
CAPSURE SENSE LEAD MRI SURESCAN
Common Device Name
ELECTRODE, PACEMAKER, PERMANENT
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key10633743
Report Number2649622-2020-19182
Device Sequence Number16795603
Product Code DTB
UDI-Device Identifier00643169411074
UDI-Public00643169411074
Combination Product (Y/N)N
Initial Reporter StateCT
Initial Reporter CountryUS
PMA/510(K) Number
P830061
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 10/06/2020
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 Date01/26/2017
Device Model Number407452
Device Catalogue Number407452
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/14/2020
Initial Report FDA Received Date10/06/2020
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
457445 LEAD, A2DR01 IPG
Patient Weight68
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