MAUDE Adverse Event Report: MPRI SELECTSECURE MRI SURESCAN; DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

Model Number	383074
Medical Device Problem Code	Under-Sensing (1661)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id 383059 lot# serial# (b)(4).Implanted: (b)(6) 2009.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient experienced chest pain, tightness and frequent ectopy (disturbance of the cardiac rhythm).The right ventricular (rv) lead exhibited undersensing.The right atrial (ra) lead exhibited lead position check failure and high thresholds.The ra and the rv lead remain in use.No further patient complications have been reported as a result of this event.

• 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 Key: 11228494
• Report Number: 2649622-2021-01595
• Device Sequence Number: 14310962
• Product Code: NVN
• UDI-Device Identifier: 00613994119957
• UDI-Public: 00613994119957
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P030036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2021

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 Date: 02/15/2009
• Device Model Number: 383074
• Device Catalogue Number: 383074
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 383059 LEAD
• Patient Age: 87 YR
• Patient Weight: 84