MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTUA; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number V273

Device Problem Battery Problem: High Impedance (2947)

Patient Problem Insufficient Information (4580)

Event Date 06/15/2021

Event Type  malfunction  

Event Description

Crt-p under bsc advisory for high battery impedance.Manufacture recommends device replacement prior to reaching eri.Patient scheduled for generator replacement.

• Brand Name: INTUA
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12127620
• MDR Text Key: 260265113
• Report Number: 12127620
• Device Sequence Number: 1
• Product Code: NKE
• 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: 06/18/2021,06/15/2021

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
• Device Operator: No Information
• Device Model Number: V273
• 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: 7 YR
• Event Location: Other
• Date Report to Manufacturer: 07/07/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA