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

Model Number U128

Device Problems Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2021

Event Type  Injury  

Manufacturer Narrative

This device has been returned for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be operating in safety mode.The device was subsequently explanted and replaced due to suspected premature battery depletion.No additional adverse patient effects were reported.

Manufacturer Narrative

This device has been returned for analysis.This report will be updated upon completion of analysis.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 both brady and tachy therapy remained available.It was noted during the interrogation that the device had intermittent telemetry; telemetry would periodically disconnect and reconnect.The pulse generator case was removed to facilitate inspection and testing of the internal components.Internal visual inspection noted no irregularities.The battery voltage was noted to drop when telemetry connection was attempted.The battery was removed and replaced with an external power source.Review of the device memory confirmed that the device detected more than two errors during a short period of time which is what caused the device to revert to safety mode; however, despite detailed testing the root cause of the errors was not able to be determined.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) was found to be operating in safety mode.The device was subsequently explanted and replaced due to suspected premature battery depletion.No additional adverse patient effects were reported.

• Brand Name: VALITUDE X4 CRT-P
• Type of Device: PULSE GENERATOR, 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: 11669110
• MDR Text Key: 245502064
• Report Number: 2124215-2021-06919
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: 00802526559402
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030005/S113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2022

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: 07/10/2017
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 702650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Initial Date Manufacturer Received: 03/12/2021
• Initial Date FDA Received: 04/15/2021
• Supplement Dates Manufacturer Received: 03/31/2022
• Supplement Dates FDA Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2015
• 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
• Patient Age: 90 YR
• Patient Sex: Male