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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI SELECTSECURE; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
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MPRI SELECTSECURE; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE Back to Search Results
Model Number 383049
Medical Device Problem Codes Under-Sensing (1661); Decreased Sensitivity (2534)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/17/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 4968-35 lead, implanted: (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the right atrial (ra) lead exhibited undersensing and very small p-waves.The ra lead was capped and replaced.No patient complications have been reported as a result of this event.
 
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Brand Name
SELECTSECURE
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 Key8604166
Report Number2649622-2019-08082
Device Sequence Number3236576
Product Code NVN
UDI-Device Identifier00643169279186
UDI-Public00643169279186
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
P030036
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/13/2019
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 Date05/21/2014
Device Model Number383049
Device Catalogue Number383049
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/17/2019
Initial Report FDA Received Date05/13/2019
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
ADDRL1 IPG, 4968-35 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age12 YR
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