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

Model Number	U226
Medical Device Problem Codes	Signal Artifact/Noise (1036); Failure to Capture (1081); High impedance (1291); High Capture Threshold (3266)
Health Effect - Clinical Codes	Dizziness (2194); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) and left ventricular (lv) lead exhibited impedance measurements of greater than 3000 ohms, increased thresholds, possible loss of lv capture, and low level noise with patient isometrics.Technical services (ts) discussed possible troubleshooting and programming options.No adverse patient effects were reported.The device system remains in service.
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) and left ventricular (lv) lead exhibited impedance measurements of greater than 3000 ohms, increased thresholds, possible loss of lv capture, and low level noise with patient isometrics.Technical services (ts) discussed possible troubleshooting and programming options.No adverse patient effects were reported.The device system remains in service.It was reported that the patient presented to the hospital following a dizzy spell.Upon interrogation of the device, the lead safety switch (lss) feature was noted to have activated due to continued high out of range pacing impedance measurements.The lv lead exhibited no capture at maximum outputs in all but two programmed vectors, and impedance spikes were observed during patient isometrics.It was reported that a chest x-ray had performed previously, however, the results were unknown.The field representative inquired if the system was magnetic resonance imaging (mri) conditional.Technical services (ts) discussed that it was not.The field representative noted that the physician planned to perform an off-label mri scan.No adverse patient effects were reported.This device remains in service.
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) and left ventricular (lv) lead exhibited impedance measurements of greater than 3000 ohms, increased thresholds, possible loss of lv capture, and low level noise with patient isometrics.Technical services (ts) discussed possible troubleshooting and programming options.No adverse patient effects were reported.The device system remains in service.It was reported that the patient presented to the hospital following a dizzy spell.Upon interrogation of the device, the lead safety switch (lss) feature was noted to have activated due to continued high out of range pacing impedance measurements.The lv lead exhibited no capture at maximum outputs in all but two programmed vectors, and impedance spikes were observed during patient isometrics.It was reported that a chest x-ray had performed previously, however, the results were unknown.The field representative inquired if the system was magnetic resonance imaging (mri) conditional.Technical services (ts) discussed that it was not.The field representative noted that the physician planned to perform an off-label mri scan.No adverse patient effects were reported.This device remains in service.
Additional 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.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 CRT-P
• Common Device Name: 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: 14549892
• Report Number: 2124215-2022-19066
• Device Sequence Number: 5157629
• Product Code: NKE
• UDI-Device Identifier: 00802526559457
• UDI-Public: 00802526559457
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P030005/S138
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/16/2020
• Device Model Number: U226
• Device Catalogue Number: U226
• Device Lot Number: 700755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 05/25/2022; 06/27/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 06/21/2022; 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male