MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VALITUDE X4 CRT-P IMPLANTABLE DEVICE

Model Number U128

Device Problems Failure to Capture (1081); Use of Device Problem (1670); Data Problem (3196)

Patient Problem Syncope (1610)

Event Date 02/23/2020

Event Type  Injury  

Event Description

It was reported that this patient presented to the emergency room (er) following a syncopal episode. A consult review performed by boston scientific technical services (ts) indicated that the left ventricular (lv) output programming on this cardiac resynchronization therapy pacemaker (crt-p) device was below the patients threshold. Evidence is suggestive that a mistake was made in the lv output programming at the last in-office device check. Ts also noted as part of the consult review that the right ventricular automatic threshold (rvat) test from the morning the patient presented to the er indicated successful right ventricular (rv) capture below the programmed rv output. In response, the physician requested that a boston scientific representative (rep) reprogram the lv output. The patient was subsequently discharged from the hospital. The device remains in-service. No additional adverse patient effects were reported.

• Brand Name: VALITUDE X4 CRT-P
• Type of Device: IMPLANTABLE DEVICE
• 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: 9973360
• MDR Text Key: 188064805
• Report Number: 2124215-2020-08157
• Device Sequence Number: 1
• Product Code: NKE
• 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

• Type of Report: Initial
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/08/2018
• Device Model Number: U128
• Device Catalogue Number: U128
• Device Lot Number: 716132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2016
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/17/2020 Patient Sequence Number: 1