MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number U228

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Fall (1848); Intracranial Hemorrhage (1891); Syncope/Fainting (4411); Asystole (4442); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2022

Event Type  Death  

Event Description

It was reported that the pacemaker entered safety mode and was subsequently replaced.The device is expected to be returned to boston scientific for analysis.No additional adverse patient effects were reported.

Event Description

It was reported that the pacemaker entered safety mode and was subsequently replaced.The device is expected to be returned to boston scientific for analysis.No additional adverse patient effects were reported.It was additionally reported that the day prior to discovering the device was in safety mode the patient experienced three or four episodes of syncope (asystole of approximately seven seconds) and as a result, had a fall.The fall caused a subarachnoid hemorrhage.It was stated that the patient was doing ok following the device replacement, though the treatment required for the hemorrhage was not reported.

Event Description

It was reported that the pacemaker entered safety mode and was subsequently replaced.The device is expected to be returned to boston scientific for analysis.No additional adverse patient effects were reported.It was additionally reported that the day prior to discovering the device was in safety mode the patient experienced three or four episodes of syncope (asystole of approximately seven seconds) and as a result, had a fall.The fall caused a subarachnoid hemorrhage.It was stated that the patient was doing ok following the device replacement, though the treatment required for the hemorrhage was not reported.The device has been received and analysis is in-progress.Additional information was received indicating the patient expired due to complications related to the previously reported fall.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode and that bradycardia therapy remained available.Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance put this device at risk of experiencing transient voltage decreases (and associated resets) during periods of high-power consumption.When battery voltage drops below a minimum threshold a system reset is performed.If three system resets occur within a 48-hour period, the device is designed to immediately enter safety mode operation to maintain back-up pacing with pre-defined, non-programmable settings.

Event Description

It was reported that the pacemaker entered safety mode and was subsequently replaced.The device is expected to be returned to boston scientific for analysis.No additional adverse patient effects were reported.It was additionally reported that the day prior to discovering the device was in safety mode the patient experienced three or four episodes of syncope (asystole of approximately seven seconds) and as a result, had a fall.The fall caused a subarachnoid hemorrhage.It was stated that the patient was doing ok following the device replacement, though the treatment required for the hemorrhage was not reported.The device has been received and analysis is in-progress.Additional information was received indicating the patient expired due to complications related to the previously reported fall.

• Brand Name: VISIONIST X4 CRT-P
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
• 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: 14733152
• MDR Text Key: 294265203
• Report Number: 2124215-2022-21877
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559471
• UDI-Public: 00802526559471
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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,Followup,Followup
• Report Date: 02/27/2023

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: 01/20/2018
• Device Model Number: U228
• Device Catalogue Number: U228
• Device Lot Number: 706812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/17/2022
• Supplement Dates Manufacturer Received: 05/30/2022; 08/26/2022; 02/02/2023
• Supplement Dates FDA Received: 06/22/2022; 09/20/2022; 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2016
• 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): Required Intervention; Death; Hospitalization; Life Threatening