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); High impedance (1291); Over-Sensing (1438); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during an implant procedure, all leads were tested in the psa and no abnormal measurements were exhibited.After connecting the left ventricular (lv) lead, high out or range (oor) pacing impedance measurements were exhibited along with noise oversensing.The lv connection was cleaned and lead tested with psa again, however, oor measurements keep exhibiting.The lv lead was connected to another pg and all measurements were within range.A connection issue was suspected.The device was successfully replaced during the same procedure.No adverse patient effects were reported.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.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.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during an implant procedure, all leads were tested in the psa and no abnormal measurements were exhibited.After connecting the left ventricular (lv) lead, high out or range (oor) pacing impedance measurements were exhibited along with noise oversensing.The lv connection was cleaned and lead tested with psa again, however, oor measurements keep exhibiting.The lv lead was connected to another pg and all measurements were within range.A connection issue was suspected.The device was successfully replaced during the same procedure.No adverse patient effects were reported.This device was received for analysis.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.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.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during an implant procedure, all leads were tested in the psa and no abnormal measurements were exhibited.After connecting the left ventricular (lv) lead, high out or range (oor) pacing impedance measurements were exhibited along with noise oversensing.The lv connection was cleaned and lead tested with psa again, however, oor measurements keep exhibiting.The lv lead was connected to another pg and all measurements were within range.A connection issue was suspected.The device was successfully replaced during the same procedure.No adverse patient effects were reported.This device was received 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 ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12221139
• MDR Text Key: 263375486
• Report Number: 2124215-2021-20176
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P030005/S138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2022
• Device Model Number: U228
• Device Catalogue Number: U228
• Device Lot Number: 757651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 07/23/2021
• Supplement Dates Manufacturer Received: 07/22/2021; 07/18/2022
• Supplement Dates FDA Received: 10/10/2021; 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1