MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY X4 STRAIGHT; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number 4671

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

Patient Problems Abscess (1690); Purulent Discharge (1812); Fever (1858); Staphylococcus Aureus (2058); Sepsis (2067); Impaired Healing (2378); No Code Available (3191)

Event Date 02/19/2020

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.(b)(4).

Event Description

It was reported that this left ventricular (lv) lead was part of a system revision due to pocket infection.Additional information received indicates that the patient presented to the hospital with fever and was initially ruled out for subsequently demonstrated staphylococcus aureus and sepsis.The patient also complained of having issues with the incision healing, stitch abscess and purulent discharge from the site.The pocket was flushed with antibiotic solution.There were no additional adverse patient effects reported.The lv lead was explanted.

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.Patient code 3191 captures the reportable event of surgery and the additional intervention treatment with the use of antibiotic solution.Upon receipt at our post market quality assurance laboratory, additional information from product investigation indicates that the returned lv lead was analyzed and visually inspected in which the lead exhibited normal characteristics and revealed no abnormalities.This supplemental is being filed to capture the product analysis from the product investigation.

Event Description

It was reported that this left ventricular (lv) lead was part of a system revision due to pocket infection.Additional information received indicates that the patient presented to the hospital with fever and was initially ruled out for subsequently demonstrated staphylococcus aureus and sepsis.The patient also complained of having issues with the incision healing, stitch abscess and purulent discharge from the site.The pocket was flushed with antibiotic solution.There were no additional adverse patient effects reported.The lv lead was explanted.

• Brand Name: ACUITY X4 STRAIGHT
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10318127
• MDR Text Key: 200236233
• Report Number: 2124215-2020-15417
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526524516
• UDI-Public: 00802526524516
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/20/2021
• Device Model Number: 4671
• Device Catalogue Number: 4671
• Device Lot Number: 829440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR