MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VITALIO¿; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number K274

Device Problem Battery Problem: High Impedance (2947)

Patient Problem Insufficient Information (4580)

Event Date 12/15/2021

Event Type  malfunction  

Event Description

Device under boston scientific advisory for high battery impedance, patient is not dependent, recommendation from manufacturer is to do generator change when battery is at 4 years remaining longevity.Remote one month ago showed ~4 years remaining until elective replacement inhibitor.Patient saw dr.And elected to schedule generator change.Patient is scheduled for generator change 1 week from now.

• Brand Name: VITALIO¿
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 13659305
• MDR Text Key: 286514440
• Report Number: 13659305
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: K274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/21/2022
• Device Age: 7 YR
• Event Location: Other
• Date Report to Manufacturer: 03/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31025 DA
• Patient Sex: Male