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 High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Defective Device (2588); Ambient Noise Problem (2877); Device Operates Differently Than Expected (2913); Device Sensing Problem (2917)

Patient Problems Complaint, Ill-Defined (2331); Injury (2348)

Event Date 02/02/2018

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected at this time, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that during a routine follow-up appointment, it was discovered that a lead safety switch occurred for this cardiac resynchronization therapy pacemaker (crt-p).The safety switch activated due to a single high out of range impedance measurement with a non-boston scientific right ventricular (rv) lead, which changed the lead configuration to unipolar.The patient was reported to be pre-syncopal and experienced symptoms of decompensation.The minute ventilation sensor was programmed off during this appointment.Data from the device memory was sent in to boston scientific technical services (ts) for review.Based on ts review, there are lead integrity concerns.The observed noise in episodes v12 and v13 did not represent typical minute ventilation oversensing; however, did show noise with oversensing and pacing inhibition.The longest pause was around 1700ms.The noise amplitudes were high enough to be sensed by the device.Ts discussed for the future follow-up appointments, obtaining an x-ray to assess any abnormality in the lead body, close monitoring of the lead impedances, sensing, and detection while the patient is doing arm movements, pocket manipulations, and posture changes.Ts also discussed running a real-time electrogram paper to document any noise reproduced by any action, and to complete all electrical measurements to determine if surgical intervention of the lead is necessary.Ts discussed the review of device data and recommendations with the field.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.

Event Description

New information received indicates the minute ventilation (mv) sensor was deactivated by the signal artifact monitor (am) due to high out-of-range impedance measurements in both chambers.The field representative recommended programming to rate response features only.No adverse patient effects were reported.The device remains in service.

• 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
• 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: 7354115
• MDR Text Key: 102933152
• Report Number: 2124215-2018-03218
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030005/S138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/16/2018
• Device Model Number: U228
• Device Catalogue Number: U228
• Device Lot Number: 709548
• Other Device ID Number: VISIONIST X4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/02/2018
• Initial Date FDA Received: 03/20/2018
• Supplement Dates Manufacturer Received: 08/29/2019
• Supplement Dates FDA Received: 09/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2016
• 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: 4076; 4677; U228
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 87 YR