MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number U228

Device Problems Pacing Problem (1439); Use of Device Problem (1670)

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

Event Date 12/15/2020

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) patient was experiencing inappropriate pacing percentages and therapy loss, despite the device programmed to left ventricular-only mode.Boston scientific technical services was contacted and it was discussed that a right ventricular (rv) lead was not implanted in the system, which is off-label usage.Because the crt-p operation is based on right ventricular (rv) based timing, it was strongly recommended to implant a rv lead to resolve the event.It is unknown if the therapy loss resulted in asystole or a health impact.Additional information has been requested regarding the event resolution and physician name, but has not yet been received.At this time, the device remains implanted and no additional adverse patient consequences were reported.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) patient was experiencing inappropriate pacing percentages and therapy loss, despite the device programmed to left ventricular-only mode.Boston scientific technical services was contacted and it was discussed that a right ventricular (rv) lead was not implanted in the system, which is off-label usage.Because the crt-p operation is based on right ventricular (rv) based timing, it was strongly recommended to implant a rv lead to resolve the event.However, despite multiple attempts, no further information was able to be provided for this event.At this time, the device remains implanted and no additional adverse patient consequences were reported.

Manufacturer Narrative

With all the available information, bsc is unable to conclude the root cause of the incident.This device has not been returned; therefore, a technical analysis cannot be conducted.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

• Brand Name: VISIONIST X4 CRT-P
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11228012
• MDR Text Key: 228620443
• Report Number: 2124215-2021-01902
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• PMA/PMN Number: P030005/S138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/07/2021

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: Lay User/Patient
• Device Expiration Date: 06/19/2021
• Device Model Number: U228
• Device Catalogue Number: U228
• Device Lot Number: 744118
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 03/03/2021
• Supplement Dates FDA Received: 04/07/2021
• Patient Sequence Number: 1