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 High impedance (1291); Device Sensing Problem (2917)

Patient Problem Atrial Fibrillation (1729)

Event Date 09/15/2018

Event Type  malfunction  

Manufacturer Narrative

Attempts were made to gather additional information regarding this event, but none was available.This investigation will be updated should further information be provided.

Event Description

It was reported that an automatic safety switch from bipolar to unipolar occurred due to a pacing impedance measurement of greater than 2000 ohms on this patient's non boston scientific left ventricular lead.There was also noise noted, although it was not impacting sensing.The patient reportedly had chronic atrial fibrillation.Boston scientific technical services provided explanation and advice to the health care provider.The cardiac resynchronization therapy defibrillator remains in service, as does the non boston scientific left ventricular lead.No adverse patient effects were noted.

Manufacturer Narrative

Attempts were made to gather additional information regarding this event, but none was available.This investigation will be updated should further information be provided.

Event Description

This supplemental report is being filed because the evaluation codes have been updated.

• 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: 8016395
• MDR Text Key: 125383495
• Report Number: 2124215-2018-60754
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: 00802526559402
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/19/2019
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 728254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2017
• 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 Age: 63 YR