MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST? CRT-P; cardiac resynchronization therapy pacemaker (CRT-P)

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	03/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) recorded a code 1003 indicative of battery voltage too low for projected remaining capacity, prior to a planned procedure.Technical services (ts) reviewed the available data and requested further data submission for analysis.Subsequent evaluation confirmed the device had triggered a remote monitoring disablement due to low battery measurement.The device was updated with the latest software; however, given the battery status and advisory conditions, replacement was recommended.No adverse patient effect were reported.This crt-p remains in service.
Additional Manufacturer Narrative
Follow up report 1 (additional information): this report is being submitted to update field b5: describe event or problem, section b and field h6: device codes, section h.The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) recorded a code 1003 indicative of battery voltage too low for projected remaining capacity, prior to a planned procedure.Technical services (ts) reviewed the available data and requested further data submission for analysis.Subsequent evaluation confirmed the device had triggered a remote monitoring disablement due to low battery measurement.The device was updated with the latest software; however, given the battery status and advisory conditions, replacement was recommended.No adverse patient effect were reported.This crt-p remains in service.Additional information was received that this crt-p was successfully explanted and replaced.No additional adverse patient effects were reported outside the revision procedure.

• Brand Name: VISIONIST? CRT-P
• Common Device Name: 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; 4100 hamline avenue north; saint paul MN 55112 -579
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 25002444
• Report Number: 2124215-2026-22628
• Device Sequence Number: 13200685
• Product Code: NKE
• UDI-Device Identifier: 00802526559457
• UDI-Public: (01)00802526559457(17)190213
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P030005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification,Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2026

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: 02/13/2019
• Device Model Number: U226
• Device Catalogue Number: U226
• Device Lot Number: 700461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Supplement Date Received by Manufacturer: 04/29/2026; 08/06/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 05/05/2026; 08/12/2026
• Date Device Manufactured: 02/27/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female