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

Model Number 4674

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Thrombosis (2100)

Event Date 05/31/2018

Event Type  Injury  

Event Description

It was reported that the patient experienced a deep vein thrombosis following the left ventricular (lv) lead implant procedure.The event was resolved with intravenous enoxaparin therapy and the lead remains implanted.The patient was stable with no additional adverse consequences.

• Brand Name: ACUITY X4 SPIRAL S
• 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): GUIDANT PUERTO RICO, B.V.; no. 12, road 698; ,; dorado PR 00646 3311
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8505067
• MDR Text Key: 141631563
• Report Number: 2124215-2019-01384
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P010012/S398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2020
• Device Model Number: 4674
• Device Catalogue Number: 4674
• Device Lot Number: 808487
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2018
• 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; Life Threatening; Required Intervention
• Patient Age: 73 YR