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); Connection Problem (2900)

Patient Problem No Code Available (3191)

Event Date 10/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination identified a hole in the left ventricular (lv) lead setscrew seal plug and other seal plugs are intact.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.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.

Event Description

It was reported that five days after implant, the physician performed an additional intervention to add a left ventricular (lv) lead to this cardiac resynchronization therapy pacemaker (crt-p).However, the device exhibited high out of range pacing impedance and noise.The lv lead was tested with a pacing system analyzer (psa) and the measurements was within range.The physician suspected device set screw issues.Subsequently, the device was explanted and replaced.A new device was implanted with good measurements.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
• 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: 11128120
• MDR Text Key: 225489372
• Report Number: 2124215-2020-27665
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: Physician
• Type of Report: Initial
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/17/2021
• Device Model Number: U225
• Device Catalogue Number: U225
• Device Lot Number: 713570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 01/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention