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

Model Number	5076-85
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the right ventricular (rv) lead was attempted, not implanted.The physician had trouble maneuvering the lead, advancing stylets, and placing the lead appropriately.Due to the lead not being common length no additional stylets were available to assist in further attempts to place the lead.A new length of lead was implanted and 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.

• 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: 6164536
• Report Number: 2649622-2016-16170
• Device Sequence Number: 19187173
• Product Code: DTB
• UDI-Device Identifier: 00643169448926
• UDI-Public: 00643169448926
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/27/2016

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: Lay User/Patient
• Device Expiration Date: 05/14/2017
• Device Model Number: 5076-85
• Device Catalogue Number: 5076-85
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2016
• Supplement Date Received by Manufacturer: 09/27/2016
• Initial Report FDA Received Date: 12/09/2016
• Supplement Report FDA Received Date: 09/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR