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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 08/26/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical devices: 419688, lead, implant date: (b)(6) 2019.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) his-bundle lead exhibited no capture.The rv his-bundle 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 Key12459564
Report Number2649622-2021-18574
Device Sequence Number3939823
Product Code NVN
UDI-Device Identifier00643169857698
UDI-Public00643169857698
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
P030036
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2021
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) 09/13/2021
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 Date09/05/2020
Device Model Number383074
Device Catalogue Number383074
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/26/2021
Initial Report FDA Received Date09/13/2021
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
W1DR01 IPG, 5076-52 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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