MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VISIONIST X4 CRT-P; CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER

Model Number U228

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Sepsis (2067); No Code Available (3191)

Event Date 01/18/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) patient indicated that their incision never healed and they were recently hit in that area.A sore and opening were noted on the incision line.Subsequently, a revision procedure was performed.This crt-p, right atrial (ra) lead, right ventricular (rv) lead, and left ventricular (lv) lead were explanted due to infection and sepsis.No additional adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) patient indicated that their incision never healed and they were recently hit in that area.A sore and opening were noted on the incision line.Subsequently, a revision procedure was performed.This crt-p, right atrial (ra) lead, right ventricular (rv) lead, and left ventricular (lv) lead were explanted due to infection and sepsis.No additional adverse patient effects were reported.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.The device was 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.

• Brand Name: VISIONIST X4 CRT-P
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11233771
• MDR Text Key: 228833750
• Report Number: 2124215-2021-02243
• 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
• 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: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/16/2020
• Device Model Number: U228
• Device Catalogue Number: U228
• Device Lot Number: 733840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR