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

Model Number	383049
Medical Device Problem Codes	Break (1069); Over-Sensing (1438); Pacing Problem (1439); High Capture Threshold (3266)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/12/2018
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 right atrial (ra) lead exhibited high thresholds and had possibly been damaged during a previous lead extraction.The physician reported the ra lead exhibited far field r-wave (ffrw) oversensing resulting in inappropriate atrial fibrillation detection and anti-tachycardia pacing therapy delivered, which produced an accelerated rhythm of atrial fibrillation (af).The ra lead remains in use.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was further reported that the ra lead was explanted and replaced.
Additional Manufacturer Narrative
Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated atrial oversensing due to far-field r-waves.Analysis of the device memory indicated atrial pacing capture threshold was elevated.If information is provided in the future, a supplemental report will be issued.

• 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 Key: 8271052
• Report Number: 2649622-2019-01210
• Device Sequence Number: 158747
• Product Code: NVN
• UDI-Device Identifier: 00643169279186
• UDI-Public: 00643169279186
• 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: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• 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 Date: 08/04/2015
• Device Model Number: 383049
• Device Catalogue Number: 383049
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2018
• Supplement Date Received by Manufacturer: 04/29/2019; 05/02/2019
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 05/02/2019; 05/13/2019
• 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: 6935M55, LEAD, DDMC3D4, ICD.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 14 YR