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

Model Number U125

Device Problems Failure to Capture (1081); Defective Device (2588)

Patient Problems Syncope (1610); Dizziness (2194)

Event Date 02/05/2019

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) patient experienced a syncopal episode.Loss of capture (loc) was observed on the right ventricular (rv) lead and left ventricular (lv) lead during telemetry.Isometrics and pocket manipulations were performed and no noise was reproduced, and the impedances were stable around 400 ohms.Data analysis showed there were issues with the right atrial (ra) lead auto threshold tests due to atrial rate to high for a test to start and fusion issues.There were no recorded errors for the rv auto threshold test.It was noted over the past few weeks the patient has experienced an increased number of presyncopal episodes.The rv ring was common to both the rv lead and lv lead pacing pathway, and it is suspected there is an intermittent issue involving the rv ring.The crt-p was reprogrammed and loc hasn't occurred since.This crt-p system remains in service.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 CLONMEL LIMITED; cashel road; ,; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8509788
• MDR Text Key: 141779035
• Report Number: 2124215-2019-04532
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/06/2019
• Device Model Number: U125
• Device Catalogue Number: U125
• Device Lot Number: 704937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2017
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 26 YR