MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VITALITY 2; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number T177

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Ambient Noise Problem (2877)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2018

Event Type  Injury  

Manufacturer Narrative

Additional information regarding the expected date of the procedure has been requested.No additional information is available at this time.If additional information becomes available this report will be updated.

Event Description

Boston scientific received information that this implantable cardioverter defibrillator (icd) and right ventricular (rv) lead exhibited noise and oversensing on the rv lead resulting in inappropriate ventricular tachycardia (vt) episodes.It was reported that the device is at eri and the lead plans to be replaced at the upcoming device replacement procedure.No adverse patient effects were reported.

Event Description

Additional information received from the local field representative indicated that the rv lead was successfully explanted during the device replacement procedure.No additional adverse patient effects were reported.

Manufacturer Narrative

The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) and the right ventricular (rv) lead exhibited noise and oversensing resulting in inappropriately recorded ventricular tachycardia episodes.This icd reached elective replacement indicator status and the rv lead was planned to be replaced at this upcoming procedure.Eventually, both of these products were replaced.This icd is not expected to be returned for analysis and no additional adverse patient effects were reported.

Manufacturer Narrative

This follow-up 001 report was not submitted previously.As per request by the fda on january 10, 2024, follow-up 001 has been resubmitted in an effort to release follow-up 002 from hold status.

• Brand Name: VITALITY 2
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 7411446
• MDR Text Key: 105154325
• Report Number: 2124215-2018-06361
• Device Sequence Number: 1
• Product Code: KRG
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P960040/S039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/18/2009
• Device Model Number: T177
• Device Catalogue Number: T177
• Device Lot Number: 117433
• Other Device ID Number: VITALITY 2 VR EL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 0158; 1852; T177
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Male