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

Model Number	5076-65
Medical Device Problem Codes	Failure to Capture (1081); Decreased Sensitivity (2534); Capturing Problem (2891); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Hiccups (1899); Cardiac Perforation (2513)
Date of Event	10/14/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported one day after implant that the patient's right ventricular (rv) lead showed rising pacing threshold, reduced sensing, and phrenic nerve stimulation.It was reported that the rv lead had likely perforated and the rv lead was repositioned.Four days later there was loss of pacing capture and an x-ray confirmed another perforation.The rv lead was explanted and replaced.No further 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.

• Brand Name: CAPSUREFIX NOVUS
• Common Device Name: ELECTRODE, PACEMAKER, PERMANENT
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 6160872
• Report Number: 2649622-2016-14264
• Device Sequence Number: 710226
• Product Code: DTB
• UDI-Device Identifier: 00643169448919
• UDI-Public: 00643169448919
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P930039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2016

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: 11/14/2016
• Device Model Number: 5076-65
• Device Catalogue Number: 5076-65
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/18/2016
• Supplement Date Received by Manufacturer: 10/18/2016
• Initial Report FDA Received Date: 12/09/2016
• Supplement Report FDA Received Date: 09/27/2017
• 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: A2DR01 IPG, 5076-45 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention