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

Model Number U225

Device Problems Signal Artifact/Noise (1036); High impedance (1291)

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

Event Date 10/15/2020

Event Type  Injury  

Event Description

It was reported that during a normal device upgrade procedure, this device exhibited noise and varying impedance measurements from 800 ohms to 1800 ohms on the left ventricular (lv) lead.After adjusting, the noise reduced, but lead pacing impedances were not stable with measurements of greater than 3000 ohms.The lead was then tested with the pacing system analyzer (psa), and no noise or out of range impedance were observed.After multiple attempts, the physician elected to plugged the lv port and reschedule the procedure.Subsequently, another procedure took place and the device was explanted.Another device and lv lead were successfully implanted.No adverse patient effects were reported.At this time, the product has been returned, investigation will be performed and this report will be updated.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a normal device upgrade procedure, this device exhibited noise and varying impedance measurements from 800 ohms to 1800 ohms on the left ventricular (lv) lead.After adjusting, the noise reduced, but lead pacing impedances were not stable with measurements of greater than 3000 ohms.The lead was then tested with the pacing system analyzer (psa), and no noise or out of range impedance were observed.After multiple attempts, the physician elected to plugged the lv port and reschedule the procedure.Subsequently, another procedure took place and the device was explanted.Another device and the lv lead were successfully implanted.No adverse patient effects were reported.

Manufacturer Narrative

The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Pacing and sensing functions were tested and the device was verified to operate as expected.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

• 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: 11227764
• MDR Text Key: 241236530
• Report Number: 2124215-2020-29023
• 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: 02/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/10/2022
• Device Model Number: U225
• Device Catalogue Number: U225
• Device Lot Number: 715787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention