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

Model Number	5076-85
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	02/10/2017
Type of Reportable Event	Death
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 is deceased.The patient passed away after an operation to remove an implantable pulse generator (ipg) system due to infection.A temporary lead was then placed.The patient passed away in the operating room after the procedure was completed.The cause of death was unable to be obtained.A review of the patient's obituary notes the patient passed away due to complications from surgery.Additional information was unable to be obtained.
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: 6404181
• Report Number: 2649622-2017-02472
• Device Sequence Number: 13612519
• Product Code: DTB
• UDI-Device Identifier: 00643169550797
• UDI-Public: 00643169550797
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P930039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2017

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/23/2018
• Device Model Number: 5076-85
• Device Catalogue Number: 5076-85
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2017
• Supplement Date Received by Manufacturer: 02/13/2017
• Initial Report FDA Received Date: 03/14/2017
• Supplement Report FDA Received Date: 10/02/2017
• 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: BIOTRONIK IPG
• Outcome Attributed to Adverse Event: Death
• Patient Age: 77 YR