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 Failure to Capture (1081); Device Sensing Problem (2917); Impedance Problem (2950); High Capture Threshold (3266)

Patient Problems Syncope (1610); Cardiac Arrest (1762)

Event Date 05/01/2018

Event Type  Injury  

Event Description

It was reported that while this pacemaker dependent patient was in the hospital, loss of right ventricular (rv) capture was noted.The patient became unresponsive and a rapid response was called.It remains unknown if the unresponsiveness was due to the loss of capture (loc).The rv output was increased to maximum.Noise was also observed on the rv channel, but it was not oversensed.Further review found that four onths earlier there were fluctuating impedance measurements from 1100 to 600 ohms and then back to 1100 ohm range again.Boston scientific technical services (ts) was consulted and discussed possibly increasing the automatic gaine control (agc) sensitivity or reprogramming it to fixed.The physician has opted to make no programming changes and will continue to monitor the patient.The cardiac resynchronization therapy pacemaker (crt-p) and rv lead remain in service and no additional adverse patient effects were reported.

• 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 CLONMEL LIMITED; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8041759
• MDR Text Key: 126248055
• Report Number: 2124215-2018-61186
• 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: Physician
• Type of Report: Initial
• Report Date: 11/06/2018

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: 03/22/2019
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 719472
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2018
• Initial Date FDA Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 89 YR