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

Model Number K277

Device Problem Battery Problem: High Impedance (2947)

Patient Problem Insufficient Information (4580)

Event Date 06/15/2021

Event Type  malfunction  

Event Description

Pacemaker under advisory for high battery impedance.Manufacturer recommends generator change prior to reaching eri.Will be scheduled for generator change soon.

• 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: 12127526
• MDR Text Key: 260261957
• Report Number: 12127526
• 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: 06/18/2021,06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: K277
• 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: 06/18/2021
• Device Age: 8 YR
• Event Location: Other
• Date Report to Manufacturer: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31025 DA