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

Model Number U228

Device Problem Migration (4003)

Patient Problems Fall (1848); Pocket Erosion (2013); Pressure Sores (2326)

Event Date 02/25/2022

Event Type  Injury  

Manufacturer Narrative

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 Description

It was reported that the patient implanted with this cardiac resynchronization therapy pacemaker (crt-p) fell down hitting the pocket area.This resulted in an open wound, the migration of the device and the creation of a pressure ulcer.Consequently, the physician decided to subject the patient to the extraction of the entire therapy system, including this device, in another specialized facility.At this time, there is no evidence that suggests this surgical procedure has been performed.No additional adverse patient effects were reported.The device remains in service.

Manufacturer Narrative

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.Correction: 1.After further investigation, it was concluded that the fall was not caused by the device, as a result, the code for this allegation was removed and a code was added to capture "erosion" as a result of the migration of the device from the implant pocket.The "pressure sore" code was also removed as it was captured in the complaint by mistake as a result of misinterpretation of information.

Event Description

It was reported that the patient implanted with this cardiac resynchronization therapy pacemaker (crt-p) fell down hitting the pocket area.This resulted in an open wound and the migration of the device.Consequently, the physician decided to subject the patient to the extraction of the entire therapy system, including this device, in another specialized facility.At this time, there is no evidence that suggests this surgical procedure has been performed.No additional adverse patient effects were reported.The device remains in service.Additional information was received indicating that this device was explanted.No additional adverse patient effects were reported.At this time, no further information is available.

• Brand Name: VISIONIST X4 CRT-P
• Type of Device: 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: 14068039
• MDR Text Key: 289015498
• Report Number: 2124215-2022-08696
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P030005/S138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/19/2022
• Device Model Number: U228
• Device Catalogue Number: U228
• Device Lot Number: 757945
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2020
• 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 Outcome(s): Hospitalization; Required Intervention