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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)
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MPRI SELECTSECURE MRI SURESCAN; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) Back to Search Results
Model Number 383074
Medical Device Problem Code Failure to Capture (1081)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/12/2020
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 loss of capture was noted on the his bundle lead.Lead was capped 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)
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key11883415
Report Number2649622-2021-10492
Device Sequence Number1388129
Product Code NVN
UDI-Device Identifier00643169857698
UDI-Public00643169857698
Combination Product (Y/N)N
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
P030036
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/26/2021
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 Date11/09/2019
Device Model Number383074
Device Catalogue Number383074
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/03/2021
Initial Report FDA Received Date05/26/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age78 YR
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