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

Model Number U128

Device Problems High impedance (1291); Over-Sensing (1438); Incorrect, Inadequate or Imprecise Result or Readings (1535); Connection Problem (2900); Interrogation Problem (4017)

Patient Problems Syncope/Fainting (4411); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/05/2022

Event Type  Injury  

Event Description

It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) stated that their remote communicator displayed a red call doctor icon.The latitude report showed this crt-p system was exhibiting high out of range pacing impedance measurements above 2000 ohms.This crt-d system remains in service.No adverse patient effects were reported.

Event Description

It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) stated that their remote communicator displayed a red call doctor icon.The latitude report showed this crt-p system was exhibiting high out of range pacing impedance measurements above 2000 ohms.This crt-p has entered safety mode.In addition, the patient appears to have had a syncopal event due to myopotential oversensing.This crt-d system remains in service.No adverse patient effects were reported.

Event Description

It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) stated that their remote communicator displayed a red call doctor icon.The latitude report showed this crt-p system was exhibiting high out of range pacing impedance measurements above 2000 ohms.This crt-p has entered safety mode.In addition, the patient appears to have had a syncopal event due to myopotential oversensing.This crt-d system remains in service.No adverse patient effects were reported.

Event Description

It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) stated that their remote communicator displayed a red call doctor icon.The latitude report showed this crt-p system was exhibiting high out of range pacing impedance measurements above 2000 ohms.This crt-p has entered safety mode.In addition, the patient appears to have had a syncopal event due to myopotential oversensing.This crt-d system remains in service.No adverse patient effects were reported.

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) stated that their remote communicator displayed a red call doctor icon.The latitude report showed this crt-p system was exhibiting high out-of-range pacing impedance measurements above 2000 ohms.This crt-p has entered safety mode.In addition, the patient appears to have had a syncopal event due to myopotential oversensing.A revision procedure was performed and the crt-p was explanted while the right ventricular lead was surgically abandoned.Both products were successfully replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.Corrected aware date.

Event Description

It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) stated that their remote communicator displayed a red call doctor icon.The latitude report showed this crt-p system was exhibiting high out-of-range pacing impedance measurements above 2000 ohms.This crt-p has entered safety mode.In addition, the patient appears to have had a syncopal event due to myopotential oversensing.A revision procedure was performed and the crt-p was explanted while the right ventricular lead was surgically abandoned.Both products were successfully replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.Corrected aware date.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/determined it had undergone resets 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 patient with this cardiac resynchronization therapy pacemaker (crt-p) stated that their remote communicator displayed a red call doctor icon.The latitude report showed this crt-p system was exhibiting high out-of-range pacing impedance measurements above 2000 ohms.This crt-p has entered safety mode.In addition, the patient appears to have had a syncopal event due to myopotential oversensing.A revision procedure was performed and the crt-p was explanted while the right ventricular lead was surgically abandoned.Both products were successfully replaced.No additional adverse patient effects were reported.

• Brand Name: VALITUDE 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: 15042836
• MDR Text Key: 296082138
• Report Number: 2124215-2022-26115
• Device Sequence Number: 1
• Product Code: NKE
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/19/2018
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 716478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2017
• 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; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Male