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

Model Number 4592

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

Patient Problem Bacterial Infection (1735)

Event Date 11/28/2022

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this left ventricular (lv) lead was part of a system revision due to infection.There were no additional adverse patient effects reported.The lv lead was explanted.

• Brand Name: ACUITY SPIRAL
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15940866
• MDR Text Key: 305071037
• Report Number: 2124215-2022-50039
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526423109
• UDI-Public: 00802526423109
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P010012/S160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/26/2023
• Device Model Number: 4592
• Device Catalogue Number: 4592
• Device Lot Number: 312804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female