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

Model Number U128

Device Problems Over-Sensing (1438); Pacing Problem (1439)

Patient Problem Asystole (4442)

Event Date 07/11/2022

Event Type  malfunction  

Event Description

It was reported that following a system upgrade procedure, the physician observed over-sensed noisy signals after pocket closure.This resulted in asystole greater than two seconds in this pacemaker dependent patient.Air bubble entrapment within the device header was the suspected cause.All other sensing parameters were stable.The physician reprogrammed the right ventricular sensitivity to prevent further over-sensing.Boston scientific technical services was contacted and recommend provocative testing at the next follow-up.It was stated the air bubbles may dissipate to resolve the event.At this time, the device remains implanted and the patient was stable with no adverse effects reported.

Event Description

It was reported that following a system upgrade procedure, the physician observed over-sensed noisy signals after pocket closure.This resulted in asystole greater than two seconds in this pacemaker dependent patient.Air bubble entrapment within the device header was the suspected cause.All other sensing parameters were stable.The physician reprogrammed the right ventricular sensitivity to prevent further over-sensing.Boston scientific technical services was contacted and recommend provocative testing at the next follow-up.It was stated the air bubbles may dissipate to resolve the event.At this time, the device remains implanted and the patient was stable with no adverse effects reported.

Manufacturer Narrative

The device was not returned and therefore complete analysis could not be performed.However, a review of evidence submitted by the field indicated that the observed noise on the ventricular channel was consistent with temporary body fluid infiltration through the seal plug, coupled with air escaping the seal plug.Setscrew seal plugs are designed to permit setscrew wrench insertion yet prevent body fluids from entering the header cavities.If an accessory sensing pathway is present due to fluid intrusion, there is a potential for oversensing and, thus, delivery of inappropriate therapy or inhibition of pacing.

• Brand Name: VALITUDE 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: 15107132
• MDR Text Key: 296781542
• Report Number: 2124215-2022-27511
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P030005/S113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2022

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: 04/13/2024
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 772935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 07/26/2022
• Supplement Dates Manufacturer Received: 08/18/2022
• Supplement Dates FDA Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1