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

Model Number 4592

Device Problem Positioning Problem (3009)

Patient Problem Vascular Dissection (3160)

Event Date 10/21/2019

Event Type  malfunction  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, an evaluation of this left ventricular (lv) lead was performed.Analysis could not confirm the difficult-to-position allegation.Visual inspection revealed no abnormalities.

Event Description

It was reported that this left ventricular (lv) lead was not implanted successfully due to placement difficulty and dissection.This lv lead was never in service.No adverse patient effects were reported.

• 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
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 9591939
• MDR Text Key: 175094897
• Report Number: 2124215-2019-28156
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526423109
• UDI-Public: 00802526423109
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S160
• 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: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/23/2019
• Device Model Number: 4592
• Device Catalogue Number: 4592
• Device Lot Number: 309228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR