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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI SELECTSECURE MRI SURESCAN; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
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MPRI SELECTSECURE MRI SURESCAN; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE Back to Search Results
Model Number 383049
Medical Device Problem Codes Failure to Capture (1081); Under-Sensing (1661); High Capture Threshold (3266)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/08/2020
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 right ventricular (rv) lead exhibited undersensing, loss of capture and high thresholds.The lead was explanted and replaced.No patient complications have been reported as a result of this event.
 
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Brand Name
SELECTSECURE MRI SURESCAN
Common Device Name
DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key10372384
Report Number2649622-2020-14963
Device Sequence Number19583453
Product Code NVN
UDI-Device Identifier00643169279186
UDI-Public00643169279186
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
P030036
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) 08/06/2020
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 Date03/02/2016
Device Model Number383049
Device Catalogue Number383049
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/17/2020
Initial Report FDA Received Date08/06/2020
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
ADSR01 IPG
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age11 YR
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