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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 Under-Sensing (1661)
Health Effect - Clinical Code Fall (1848)
Date of Event 07/24/2021
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 patient experienced a fall.It was also noted that both the right atrial (ra) lead and right ventricular (rv) lead were undersensing.Both leads remains in use. no further 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 Key12311700
Report Number2649622-2021-16333
Device Sequence Number4447828
Product Code NVN
UDI-Device Identifier00643169535855
UDI-Public00643169535855
Combination Product (Y/N)N
Initial Reporter StateIA
Initial Reporter CountryUS
PMA/510(K) Number
P030036
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 08/12/2021
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 Date10/27/2018
Device Model Number383074
Device Catalogue Number383074
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/24/2021
Initial Report FDA Received Date08/12/2021
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
A2DR01 IPG, 5076-52 LEAD
Patient Age75 YR
Patient Weight70
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