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

Model Number	5038-58
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2019
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 implantable pulse generator (ipg) exhibited loss of pacing and it was noted that the patient's heart rate went below programmed parameters on their ipg.The right atrial (ra) lead exhibited undersensing and noise.The right ventricular (rv) lead also exhibited t-wave oversensing (twos).The ipg was replaced with a bi-ventricular (bi-v) ipg and both pacing leads remain in use.No patient complications have been reported as a result of this event.

• Brand Name: CAPSURE VDD-2 LEAD
• Common Device Name: PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 11683988
• Report Number: 2649622-2021-07560
• Device Sequence Number: 3015410
• Product Code: DXY
• UDI-Device Identifier: 00885074201566
• UDI-Public: 00885074201566
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P890003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2021

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: 09/08/2012
• Device Model Number: 5038-58
• Device Catalogue Number: 5038-58
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 04/19/2021
• 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: ADDR01 IPG
• Patient Age: 40 YR