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

Model Number	5038-58
Medical Device Problem Codes	Failure to Capture (1081); Under-Sensing (1661)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Ventricular Fibrillation (2130)
Date of Event	10/28/2021
Type of Reportable Event	Serious Injury
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 patient experienced cardiac arrest (ventricular fibrillation (vf)) and bradycardia arrest.It was also reported that the right ventricular (rv) lead exhibited undersensing and no capture.The patient was externally defibrillated.The rv lead remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: CAPSURE VDD-2 LEAD
• Common Device Name: IMPLANTABLE PACEMAKER PULSE-GENERATOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 12877360
• Report Number: 2649622-2021-23543
• Device Sequence Number: 4472380
• Product Code: DXY
• UDI-Device Identifier: 00643169325678
• UDI-Public: 00643169325678
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P890003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/26/2021

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: 09/20/2020
• Device Model Number: 5038-58
• Device Catalogue Number: 5038-58
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 11/26/2021
• Date Device Manufactured: 10/18/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: W1DR01 IPG
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Weight: 97 KG