MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

Model Number U228

Device Problems Over-Sensing (1438); Ambient Noise Problem (2877); Connection Problem (2900); Device Sensing Problem (2917)

Patient Problem Syncope (1610)

Event Date 03/07/2018

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete. This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that the patient implanted with this cardiac resynchronization therapy pacemaker (crt-p) and competitor leads experienced a syncopal episode. Upon checking the device, instances of noise and oversensing were observed on both the right atrial (ra) and right ventricular (rv) leads though it was noted the recorded episode did not correspond to the time of the patient's syncope. Boston scientific technical services (ts) discussed that without further information the cause of the patient's syncope nor noise could be conclusively determined. Additional system testing was advised. The patient subsequently underwent provocation testing at which time noise was recreated with bipolar sensing programmed. An x-ray was then performed and the terminal pins of both leads could not be clearly visualized through the device header. A revision procedure was then performed wherein the leads were reinserted into the header. No additional adverse patient effects were reported. This system remains in service.

Manufacturer Narrative

No further information has been provided to date. This report will be updated should additional information become available.

Event Description

Additional information was received indicating intermittent episodes of noise and oversensing resulting in pacing inhibition continue to be observed. It was noted there have been no fluctuations in lead impedance measurements and noise is difficult to reproduce. Engineering level analysis determined the noise was likely not consistent with a device hardware issue. Ts provided suggestions for additional assessment of the leads and programming options. The device was programmed to fixed sensitivity. Despite the periods of pacing inhibition the patient remains asymptomatic. This system remains in service.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed. A visual inspection of the device header and case noted no anomalies. Pin gauge testing, designed to verify proper port dimensions, was completed. Each port measured as expected. The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested. Impedance testing was completed and all measurements were within normal limits. The device operated appropriately with no interruptions in therapy output at the returned programmed settings. A series of electrical tests was also performed, and again, normal device function was observed.

Event Description

New information received indicates that the device was explanted and returned for analysis.

• Brand Name: VISIONIST 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 CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 7362292
• MDR Text Key: 103193341
• Report Number: 2124215-2018-05043
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/09/2018
• Device Model Number: U228
• Device Catalogue Number: U228
• Device Lot Number: 715050
• Other Device ID Number: VISIONIST X4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: No Information
• Date Manufacturer Received: 10/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/22/2018 Patient Sequence Number: 1

Treatment

5076; U228