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 Telemetry Discrepancy (1629); Defective Device (2588)

Patient Problems Presyncope (4410); Syncope/Fainting (4411)

Event Date 01/06/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) underwent left ventricular (lv) threshold testing, but the health care professional (hcp) was unable to terminate the threshold test.The device recorded greater than two seconds of asystole, and a later report noted greater than ten seconds of asystole.The patient had symptoms of near fainting.The programmer exhibited an error message.One report noted that stat pace was pressed, but another report noted it was not pressed.After this, lv threshold testing was stopped, and the check was completed.Device data was preserved and submitted for boston scientific engineering review.Engineering analysis showed they were unable to determine the root cause of why the message was displayed, but it was indicative of poor telemetry or telemetry noise.No additional adverse patient effects were reported.The device remains in service.

Event Description

It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) underwent left ventricular (lv) threshold testing, but the health care professional (hcp) was unable to terminate the threshold test.The device recorded greater than two seconds of asystole, and a later report noted greater than ten seconds of asystole.The patient had symptoms of near fainting.The programmer exhibited an error message.One report noted that stat pace was pressed, but another report noted it was not pressed.After this, lv threshold testing was stopped, and the check was completed.Device data was preserved and submitted for boston scientific engineering review.Engineering analysis showed they were unable to determine the root cause of why the message was displayed, but it was indicative of poor telemetry or telemetry noise.No additional adverse patient effects were reported.The device remains in service.Additional information was received which reported that the patient experienced syncope with the previously reported issues.It was also noted that there was not greater than ten seconds of asystole, and that stat pace was pressed, which was successful.No additional adverse patient effects were reported.The device remains in service.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 11363326
• MDR Text Key: 233020017
• Report Number: 2124215-2021-03821
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: 00802526559402
• Combination Product (y/n): N
• PMA/PMN Number: P030005/S113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/13/2018
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 716400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 72 YR