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)

Patient Problems Syncope/Fainting (4411); Asystole (4442)

Event Date 11/23/2023

Event Type  malfunction  

Event Description

It was reported that one day after this cardiac resynchronization therapy pacemaker (crt-p) implant, the right ventricular (rv) lead exhibited loss of capture (loc).The patient exhibits third degree atrio-ventricular block and no intrinsic backup rhythm.The rv lead was confirmed to be dislodged due to out of range pacing impedance measurements and no capture in unipolar or bipolar configuration.The device was then programmed to left ventricular (lv) lead only.The patient then experienced an asystolic event due to an unknown cause, and the rv lead was revised and repositioned.One day later, the rv lead exhibited out of range pacing impedance measurements again and the patient presented syncope due to being pacemaker dependent and the crt-p not providing appropriate pacing.The patient is now reluctant to go back in-clinic again for another lead revision, therefore, the health care professional (hcp) requested advice on further options.The crt-d and rv lead remain in service.No additional adverse patient effects were reported.

Event Description

It was reported that one day after this cardiac resynchronization therapy pacemaker (crt-p) implant, the right ventricular (rv) lead exhibited loss of capture (loc).The patient exhibits third degree atrio-ventricular block and no intrinsic backup rhythm.The rv lead was confirmed to be dislodged due to out of range pacing impedance measurements and no capture in unipolar or bipolar configuration.The device was then programmed to left ventricular (lv) lead only.The patient then experienced an asystolic event due to an unknown cause, and the rv lead was revised and repositioned.One day later, the rv lead exhibited out of range pacing impedance measurements again and the patient presented syncope due to being pacemaker dependent and the crt-p not providing appropriate pacing.The patient is now reluctant to go back in-clinic again for another lead revision, therefore, the health care professional (hcp) requested advice on further options.The crt-d and rv lead remain in service.No additional adverse patient effects were reported.

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 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.

Event Description

It was reported that one day after this cardiac resynchronization therapy pacemaker (crt-p) implant, the right ventricular (rv) lead exhibited loss of capture (loc).The patient exhibits third degree atrio-ventricular block and no intrinsic backup rhythm.The rv lead was confirmed to be dislodged due to out of range pacing impedance measurements and no capture in unipolar or bipolar configuration.The device was then programmed to left ventricular (lv) lead only.The patient then experienced an asystolic event due to an unknown cause, and the rv lead was revised and repositioned.One day later, the rv lead exhibited out of range pacing impedance measurements again and the patient presented syncope due to being pacemaker dependent and the crt-p not providing appropriate pacing.The patient is now reluctant to go back in-clinic again for another lead revision, therefore, the health care professional (hcp) requested advice on further options.The crt-d and rv lead remain in service.No additional adverse patient effects were reported.

• 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: 18342221
• MDR Text Key: 331062147
• Report Number: 2124215-2023-71523
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2024

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 Model Number: U228
• Device Catalogue Number: U228
• Device Lot Number: 791689
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2023
• Initial Date FDA Received: 12/17/2023
• Supplement Dates Manufacturer Received: 12/26/2023; 01/03/2024
• Supplement Dates FDA Received: 12/26/2023; 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1