MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INVIVE CRT-P V173; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number V173

Device Problems Pacemaker Found in Back-Up Mode (1440); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 02/16/2021

Event Type  Injury  

Event Description

Boston scientific crt pacemaker model iv 173, serial (b)(4).A device fault was identified on (b)(6) 2021 and the device switched to safety mode.Fda safety report id# (b)(4).

• Brand Name: INVIVE CRT-P V173
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION ; marlborough MA 01752 123
• MDR Report Key: 11693169
• MDR Text Key: 246560189
• Report Number: MW5100860
• Device Sequence Number: 1
• Product Code: NKE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 143