MAUDE Adverse Event Report: MPRI CAPSURE VDD 2; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

Model Number	5038-65
Medical Device Problem Code	Under-Sensing (1661)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/30/2017
Type of Reportable Event	Malfunction
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 pacing lead exhibited intermittent atrial undersensing.The lead remains in use.No patient complications have been reported as a result of this event.

• Brand Name: CAPSURE VDD 2
• Common Device Name: PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 7258266
• Report Number: 2649622-2018-02606
• Device Sequence Number: 16178179
• Product Code: DXY
• UDI-Device Identifier: 00885074201573
• UDI-Public: 00885074201573
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P890003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/08/2018

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: 06/23/2010
• Device Model Number: 5038-65
• Device Catalogue Number: 5038-65
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2017
• Initial Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR