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

Model Number U125

Device Problems Signal Artifact/Noise (1036); High impedance (1291); High Capture Threshold (3266)

Patient Problems Syncope (1610); Syncope/Fainting (4411)

Event Date 01/02/2020

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) system exhibited intermittent high out of range pace impedance measurements as well as intermittent high thresholds on the right ventricular (rv) channel.The high impedance spikes were first observed approximately one (1) month ago.There was also an associated lead safety switch (lss) noted.In addition, some noise was observed during isometric testing.The rv lead is not a boston scientific product.The patient reported to have had an episode of syncope approximately two (2) weeks ago.The device was subsequently programmed to unipolar pacing and the patient was admitted to the hospital.The boston scientific representative indicated they will discuss a possible device and rv lead replacement with the physician.The products remain in-service at this time.No additional adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) system exhibited intermittent high out of range pace impedance measurements as well as intermittent high thresholds on the right ventricular (rv) channel.The high impedance spikes were first observed approximately one (1) month prior.There was also an associated lead safety switch (lss) noted.In addition, some noise was observed during isometric testing.The right atrial (ra), rv and left ventricular (lv) leads are not boston scientific products.The patient reported having an episode of syncope approximately two (2) weeks prior.The device was subsequently programmed to unipolar pacing and the patient was admitted to the hospital.The boston scientific representative indicated they will discuss a possible device and rv lead replacement with the physician.The entire system was subsequently explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.This correction supplemental report was submitted based on subsequent information that when the crt-p system, including this crt-p device, was replaced, it was not explanted but was deactivated and remains implanted.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) system exhibited intermittent high out of range pace impedance measurements as well as intermittent high thresholds on the right ventricular (rv) channel.The high impedance spikes were first observed approximately one (1) month prior.There was also an associated lead safety switch (lss) noted.In addition, some noise was observed during isometric testing.The right atrial (ra), rv and left ventricular (lv) leads are not boston scientific products.The patient reported having an episode of syncope approximately two (2) weeks prior.The device was subsequently programmed to unipolar pacing and the patient was admitted to the hospital.The boston scientific representative indicated they will discuss a possible device and rv lead replacement with the physician.The entire system was subsequently explanted and replaced.No additional adverse patient effects were reported.Subsequent information was received that when this crt-p system was replaced, it was not explanted but was deactivated and remains implanted.No additional adverse patient effects were reported.

• Brand Name: VALITUDE 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: 9924578
• MDR Text Key: 186721603
• Report Number: 2124215-2020-03708
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559389
• UDI-Public: 00802526559389
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2024

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: 08/24/2019
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 706823
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2020
• Initial Date FDA Received: 04/03/2020
• Supplement Dates Manufacturer Received: 02/06/2020; 04/26/2024
• Supplement Dates FDA Received: 04/25/2020; 05/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female