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

Model Number U225

Device Problems Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); High Capture Threshold (3266)

Patient Problem Syncope (1610)

Event Date 03/10/2020

Event Type  Injury  

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted. Investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation/ respiratory sensor that can be related to a high impedance condition. Additionally, the investigation determined that this device exhibited intermittent impedance measurements with no conclusive evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.

Event Description

It was reported that this patient experienced syncope. It was determined that this cardiac resynchronization therapy pacemaker (crt-p) and competitor's epicardial leads exhibited loss of capture and high and intermittent pacing threshold measurements. The physician elected in reprogram the ventricular output. Technical services reviewed the available device data and found intermittent high, out-of-range pacing impedance measurements on the ra and rv leads. Noise consistent with minute ventilation (mv) sensor was observed. Technical services discussed the mv sensor was disabled by the signal artifact monitor (sam) and noted the mv sensor should not be used with epicardial leads. At this time, there is no evidence of surgical intervention. This system remains in service. No additional adverse patient effect were reported.

• Brand Name: VISIONIST 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 CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 9975569
• MDR Text Key: 188137984
• Report Number: 2124215-2020-06704
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P030005/S138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/08/2020

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: 01/08/2020
• Device Model Number: U225
• Device Catalogue Number: U225
• Device Lot Number: 708066
• 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: 08/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2018
• 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