MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P)

Model Number U228

Device Problems Signal Artifact/Noise (1036); High impedance (1291); Battery Problem (2885)

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

Event Date 04/25/2021

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) had a not expected decrease in battery. It was noted the left ventricular (lv) lead had an abrupt drop in the impedance and a lead safety switch from the lv lead was recorded on (b)(6) 2021 due to one pacing impedance measurement high out of range. Noise was also noted in the unipolar configuration from myopotential. Reportedly, the battery depletion from the crt-p was noted when the configuration was changed from bipolar to unipolar. Technical services (ts) provided troubleshooting options for the best configuration possible and the device was reprogrammed. The crt-p system remains in service at this time and will continue to monitor the patient. No adverse patient effects were reported.

• Brand Name: VISIONIST X4 CRT-P
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (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: 12620325
• MDR Text Key: 276602635
• Report Number: 2124215-2021-24429
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559471
• UDI-Public: 00802526559471
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030005/S138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/12/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/06/2021
• Device Model Number: U228
• Device Catalogue Number: U228
• Device Lot Number: 748020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2019
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial