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

Model Number U225

Device Problems Difficult to Insert (1316); Material Integrity Problem (2978)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2020

Event Type  malfunction  

Event Description

It was reported that during a box change procedure, this cardiac resynchronization therapy pacemaker (crt-p) was an attempted implant.The physician was unable to connect the right atrial (ra) lead into the ra port.It was not possible to advance the lead three-quarters of the way into the port, therefore the lead tip did not reach the set screw.The lead was able to be inserted and connected onto the right ventricular port.This device was replaced and the second device did not encountered any header issues.No adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, under-insertion of the lead terminal pin into the device header was suspected to be the cause of the insertion difficulty but this could not be confirmed during laboratory analysis.Note that boston scientific has a vigilant quality monitoring system and we aggressively monitor field performance of all our products.We will continue to monitor for similar events.

Event Description

It was reported that during a box change procedure, this cardiac resynchronization therapy pacemaker (crt-p) was an attempted implant.The physician was unable to connect the right atrial (ra) lead into the ra port.It was not possible to advance the lead three-quarters of the way into the port, therefore the lead tip did not reach the set screw.The lead was able to be inserted and connected onto the right ventricular port.This device was replaced and the second device did not encountered any header issues.No adverse patient effects 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
• MDR Report Key: 11220874
• MDR Text Key: 258431853
• Report Number: 2124215-2021-01675
• Device Sequence Number: 1
• Product Code: NKE
• 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
• Report Date: 10/10/2021

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: 09/02/2022
• Device Model Number: U225
• Device Catalogue Number: U225
• Device Lot Number: 716876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/24/2021
• Supplement Dates Manufacturer Received: 09/02/2021
• Supplement Dates FDA Received: 10/10/2021
• Patient Sequence Number: 1