MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST CRT-P; IMPLANTABLE PACEMAKER

Model Number U225

Device Problems Signal Artifact/Noise (1036); False Positive Result (1227); Over-Sensing (1438); Pacing Problem (1439)

Patient Problems Malaise (2359); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/02/2024

Event Type  malfunction  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited noise and oversensing.Due to this, the minute ventilation (mv) rate response was not as expected.Further evaluation of the system was performed and technical services provided reprograming options.This device remains in service.No further adverse patient effects were reported.

Manufacturer Narrative

Additional information was added to the following fields: b5: describe event or problem field.H6: device codes.H6: patient codes.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited noise and oversensing.Due to this, the minute ventilation (mv) rate response was not as expected.Further evaluation of the system was performed and technical services provided reprograming options.This device remains in service.No further adverse patient effects were reported.Additional information was received detailing that the patient has not been feeling well.Additionally, a signal artifact monitoring (sam) episode due to atrial fibrillation was observed.Further device optimization options were discussed.Furthermore, a recommendation of evaluation of the patient for possible heart failure symptoms was discussed, due to, the reviewed intrinsic activity.This device remains in service.No further adverse patient effects were reported.

• Brand Name: VISIONIST CRT-P
• Type of Device: IMPLANTABLE 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: 19155029
• MDR Text Key: 341124321
• Report Number: 2124215-2024-24272
• Device Sequence Number: 1
• Product Code: NKE
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/20/2024

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 Expiration Date: 01/13/2024
• Device Model Number: U225
• Device Catalogue Number: U225
• Device Lot Number: 721501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/22/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 54 YR