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

Model Number	5554-45
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/19/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the right atrial (ra) lead had dislodged shortly after implant.The lead was explanted and replaced.No patient complications have been reported as a result of this event.

• Brand Name: CAPSURE Z NOVUS
• Common Device Name: ELECTRODE, PACEMAKER, PERMANENT
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 6780985
• Report Number: 2649622-2017-08648
• Device Sequence Number: 18887282
• Product Code: DTB
• UDI-Device Identifier: 00643169638785
• UDI-Public: 00643169638785
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P850089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2017

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/06/2018
• Device Model Number: 5554-45
• Device Catalogue Number: 5554-45
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2017
• Initial Report FDA Received Date: 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR