MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST? CRT-P; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

Model Number	U226
Medical Device Problem Codes	Premature Discharge of Battery (1057); Use of Device Problem (1670); Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) recorded a code 1003, indicating the voltage is too low for the projected remaining capacity.A request was made to have data from this device analyzed.Data analysis identified potential high impedance within the battery.In addition, remote monitoring was disable.Device replacement was recommended.No adverse patient effects were reported.This device remains in service at this time.
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) recorded a code 1003, indicating the voltage is too low for the projected remaining capacity.A request was made to have data from this device analyzed.Data analysis identified potential high impedance within the battery.In addition, remote monitoring was disable.Device replacement was recommended.No adverse patient effects were reported.\ \ additional information was received indicating that this crt-p was subsequently explanted and another crt-p was implanted to complete this procedure.This crt-p has not been returned at this time.No additional adverse patient effects were reported.

• Brand Name: VISIONIST? CRT-P
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER
• 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: 25479952
• Report Number: 2124215-2026-31397
• Device Sequence Number: 5700580
• Product Code: NKE
• UDI-Device Identifier: 00802526559457
• UDI-Public: (01)00802526559457(17)190109
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P030005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2026

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/09/2019
• Device Model Number: U226
• Device Catalogue Number: U226
• Device Lot Number: 700391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Supplement Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 06/11/2026
• Supplement Report FDA Received Date: 07/08/2026
• Date Device Manufactured: 01/28/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male