MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY X4 STRAIGHT; IMPLANTABLE LEAD

Model Number 4671

Device Problems Failure to Capture (1081); Device Dislodged or Dislocated (2923)

Patient Problem Twiddlers Syndrome (4563)

Event Date 06/28/2022

Event Type  Injury  

Event Description

It was reported that a left ventricular (lv) lead was dislodged due to patient having twiddlers syndrome leading to loss of capture.Dislodgment was confirmed through x-ray and loss of capture was confirmed through threshold testing.Lead was explanted and replaced with a new lead.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Testing was completed to assess lead electrical performance and inner and outer insulation integrity.Measurements throughout these tests were within normal limits.Visual inspection revealed a twist in the lead body, confirming dislodgement and twiddler's syndrome.

Event Description

It was reported that a left ventricular (lv) lead was dislodged due to patient having twiddlers syndrome leading to loss of capture.Dislodgment was confirmed through x-ray and loss of capture was confirmed through threshold testing.Lead was explanted and replaced with a new lead.No additional adverse patient effects were reported.

• Brand Name: ACUITY X4 STRAIGHT
• Type of Device: IMPLANTABLE LEAD
• 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: 15048879
• MDR Text Key: 296123646
• Report Number: 2124215-2022-26261
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526524516
• UDI-Public: 00802526524516
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P010012/S398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/18/2024
• Device Model Number: 4671
• Device Catalogue Number: 4671
• Device Lot Number: 855549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/18/2022
• Supplement Dates Manufacturer Received: 08/11/2022
• Supplement Dates FDA Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2022
• 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: 77 YR
• Patient Sex: Female