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 Signal Artifact/Noise (1036); High impedance (1291); High Capture Threshold (3266)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the lead safety switch (lss) had been triggered for this system due to a pacing impedance measurement greater than 3000 ohms on the right ventricular channel.Additionally, myopotential noise and elevated threshold measurements were observed.The physician reprogrammed the device back to bipolar configuration and no noise was observed, and impedance measurements were within range.The physician left the device in bipolar sensing and unipolar pacing.A boston scientific technical services consultant documented the reported clinical observations.The system remains implanted.The associated rv lead is manufactured by a boston scientific competitor.No adverse patient effects were reported.

Event Description

It was reported that the lead safety switch (lss) had been triggered for this system due to a pacing impedance measurement greater than 3000 ohms on the right ventricular (rv) channel.Additionally, myopotential noise and elevated threshold measurements were observed.The physician reprogrammed the device back to bipolar configuration and no noise was observed, and impedance measurements were within range.The physician left the device in bipolar sensing and unipolar pacing.A boston scientific technical services consultant documented the reported clinical observations.The system remains implanted.The associated rv lead is manufactured by a boston scientific competitor.No adverse patient effects were reported.

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.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 product performance issue or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.Investigation has determined that this type of event is likely the result of an intermittent high impedance condition associated with the device spring contact and lead terminal ring.A design enhancement was implemented in 2020 to stabilize the electrical connection between the spring contact and the lead terminal.

• 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 ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18744683
• MDR Text Key: 336673842
• Report Number: 2124215-2024-10234
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P030005/S138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/19/2020
• Device Model Number: U228
• Device Catalogue Number: U228
• Device Lot Number: 731706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Female