MAUDE Adverse Event Report: MPRI CAPSUREFIX NOVUS; ELECTRODE, PACEMAKER, PERMANENT

Model Number	5076-45
Medical Device Problem Code	Under-Sensing (1661)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient's implantable cardioverter defibrillator (icd) was experiencing frequent intermittent atrial undersensing.The device was already programmed at its most sensitive setting.The device is still 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.
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 patient's right atrial (ra) lead was experiencing frequent intermittent atrial undersensing.The lead was already programmed at its most sensitive setting.The lead is still in use.No patient complications have been reported as a result of this event.(b)(6) 2018: it was further reported that the lead was reprogrammed.The patient is a participant in the product surveillance registry clinical study.

• Brand Name: CAPSUREFIX NOVUS
• Common Device Name: ELECTRODE, PACEMAKER, PERMANENT
• Manufacturer (Section D): MPRI; road 149 km 56.3; ceiba norte industrial park; villalba PR 00766
• MDR Report Key: 6465832
• Report Number: 3004209178-2017-07233
• Device Sequence Number: 1121432
• Product Code: DTB
• UDI-Device Identifier: 00613994714695
• UDI-Public: 00613994714695
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P930039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/25/2018

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: 06/28/2014
• Device Model Number: 5076-45
• Device Catalogue Number: 5076-45
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2017
• Supplement Date Received by Manufacturer: 01/04/2017; 03/13/2018
• Initial Report FDA Received Date: 04/06/2017
• Supplement Report FDA Received Date: 09/29/2017; 04/25/2018
• 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: 5076 LEAD, 6935 LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR