MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P; IMPLANTABLE PACEMAKER

Model Number U128

Device Problems Over-Sensing (1438); Pacing Problem (1439); Incorrect, Inadequate or Imprecise Result or Readings (1535); Under-Sensing (1661)

Patient Problems Device Overstimulation of Tissue (1991); Syncope/Fainting (4411); Asystole (4442)

Event Date 01/21/2023

Event Type  Injury  

Event Description

It was reported that this implantable pacemaker exhibited oversensing and pacing inhibition of less than two seconds on the right ventricular (rv) channel.Due to this the patient experienced a syncope episode.Boston scientific technical services (ts) discussed the option to have the device reprogrammed and consider a lead revision.It was decided to reprogram the device and address the issue when the device reaches elective replacement indicator (eri).This device remains in service.No adverse patient effects were reported.

Manufacturer Narrative

Additional information was added to the following fields: b1: adverse event/product problem b2: outcome attributed to adverse event b5: describe event or problem field d6b: explant date h1: type of reportable event h6: patient codes h6: device codes h6: impact codes.

Event Description

It was reported that this implantable pacemaker exhibited oversensing and pacing inhibition of less than two seconds on the right ventricular (rv) channel.Due to this the patient experienced a syncope episode.Boston scientific technical services (ts) discussed the option to have the device reprogrammed and consider a lead revision.It was decided to reprogram the device and address the issue when the device reaches elective replacement indicator (eri).This device remains in service.No adverse patient effects were reported.Additional information was received detailing that the device had entered in safety mode and the left ventricular channel exhibited undersensing.Additionally diaphragmatic stimulation was observed.Replacement of the device was recommended.This device was explanted and replaced.No further adverse patient effects were reported.

• Brand Name: VALITUDE X4 CRT-P
• Type of Device: IMPLANTABLE 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: 16426449
• MDR Text Key: 310047815
• Report Number: 2124215-2023-08435
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/18/2017
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 702176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2023
• Initial Date FDA Received: 02/23/2023
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2015
• 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 Age: 74 YR
• Patient Sex: Female