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

Model Number U225

Device Problems Pocket Stimulation (1463); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 03/29/2021

Event Type  Injury  

Event Description

It was reported that during routine follow up this device was found to be in a safety mode status.This patient was also noted to have experienced twitches within the device pocket.Currently, this device remains in service.No adverse patient effects were reported.

Event Description

It was reported that during routine follow up this cardiac resynchronization therapy pacemaker (crt-p) was found to be in a safety mode status.This patient was also noted to have experienced twitches within the device pocket.This device was explanted and replaced.No additional adverse patient effects were reported.

Event Description

It was reported that during routine follow up this cardiac resynchronization therapy pacemaker (crt-p) was found to be in a safety mode status.This patient was also noted to have experienced twitches within the device pocket.This device was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.The device was interrogated with a programmer and confirmed to be operating in safety mode.Device memory was unavailable for review.The device case was removed to facilitate inspection and testing of the internal components.The battery was disconnected from the hybrid assembly and detailed testing determined that this device experienced high impedance in the battery, resulting in resets and reversion to safety mode.However, a definitive cause of this high impedance behavior has not been determined to date.

• Brand Name: VISIONIST CRT-P
• Type of Device: IMPLANTABLE DEVICE
• 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: 11713473
• MDR Text Key: 247024041
• Report Number: 2124215-2021-07358
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559426
• UDI-Public: 00802526559426
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030005/S138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2022

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/08/2017
• Device Model Number: U225
• Device Catalogue Number: U225
• Device Lot Number: 701110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/23/2021
• Supplement Dates Manufacturer Received: 03/31/2021; 10/31/2022
• Supplement Dates FDA Received: 04/24/2021; 11/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2015
• 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