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 Signal Artifact/Noise (1036); Over-Sensing (1438); Low impedance (2285); Device Sensing Problem (2917); Interrogation Problem (4017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2019

Event Type  Injury  

Manufacturer Narrative

Records indicate this product remains in service.This report will be updated should additional information become available.

Event Description

It was reported that the field was having difficulty establishing telemetry with this cardiac resynchronization therapy pacemaker (crt-p).The field had also reported previous episodes involving oversensing of noise as well as a low out of range pacing impedance measurement of less than 200 ohms.Device data sent in for review indicated the device was operating normally during the wanded session and was not able to switch on the radio frequency telemetry once the wand was removed multiple times.No further changes were noted and the crt-p remains in service.No adverse patient effects were reported.

Manufacturer Narrative

This product has been returned back from the field for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that the field was having difficulty establishing telemetry with this cardiac resynchronization therapy pacemaker (crt-p).The field had also reported previous episodes involving oversensing of noise as well as a low out of range pacing impedance measurement of less than 200 ohms.Device data sent in for review indicated the device was operating normally during the wanded session and was not able to switch on the radio frequency telemetry once the wand was removed multiple times.No further changes were noted and the crt-p remains in service.No adverse patient effects were reported.Additional information provided from the field indicated the crt-p was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

This device was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.The device had no telemetry upon return.The device case was opened to facilitate analysis of the internal components.Analysis confirmed there was no rf telemetry due to corrosion on the mics module.This anomaly resulted in the reported clinical observations.

Event Description

It was reported that the field was having difficulty establishing telemetry with this cardiac resynchronization therapy pacemaker (crt-p).The field had also reported previous episodes involving oversensing of noise as well as a low out of range pacing impedance measurement of less than 200 ohms.Device data sent in for review indicated the device was operating normally during the wanded session and was not able to switch on the radio frequency telemetry once the wand was removed multiple times.No further changes were noted and the crt-p remains in service.No adverse patient effects were reported.Additional information provided from the field indicated the crt-p was explanted and replaced.No additional adverse patient effects were reported.

• 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
• MDR Report Key: 8857689
• MDR Text Key: 153168266
• Report Number: 2124215-2019-15814
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559471
• UDI-Public: 00802526559471
• Combination Product (y/n): N
• PMA/PMN Number: P030005/S138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/11/2018
• Device Model Number: U228
• Device Catalogue Number: U228
• Device Lot Number: 711598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Date Manufacturer Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 76 YR