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

Model Number	383074
Medical Device Problem Codes	Failure to Capture (1081); High Capture Threshold (3266); Unstable Capture Threshold (3269)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2019
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 during attempts to implant the right ventricular (rv) lead high thresholds, unstable thresholds and no capture were observed.The rv lead was removed and replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
The full lead was returned and analyzed.No anomalies were found.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during attempts to implant the right ventricular (rv) lead, high thresholds, unstable thresholds and no capture were observed.The rv lead was removed and replaced.No patient complications have been reported as a result of this event.

• 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: 8308592
• Report Number: 2649622-2019-01934
• Device Sequence Number: 46680
• Product Code: NVN
• UDI-Device Identifier: 00643169857698
• UDI-Public: 00643169857698
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P030036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2019

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: Health Professional
• Device Expiration Date: 08/16/2020
• Device Model Number: 383074
• Device Catalogue Number: 383074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 62