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

Model Number 4674

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Twiddlers Syndrome (4563)

Event Date 10/18/2022

Event Type  Injury  

Event Description

It was reported that this left ventricular (lv) lead was explanted due to a dislodgement suspected by the patient having twiddlers syndrome.A new lv lead was successfully implanted.No additional patient adverse effects were reported.This lead was returned to boston scientific for analysis.

Manufacturer Narrative

This lead was thoroughly inspected and analyzed upon receipt at our quality assurance laboratory.Damage to the lead was noted.Due to the location and morphology of damage to the lead it is likely that external stress applied to the lead body resulted in the dislodgement.Past experience suggests patient manipulation of the lead through the skin (i.E., twiddler's syndrome) is a contributing factor to damage of this type.

Event Description

It was reported that this left ventricular (lv) lead was explanted due to a dislodgement suspected by the patient having twiddlers syndrome.A new lv lead was successfully implanted.No additional patient adverse effects were reported.This lead was returned to boston scientific for analysis.

• Brand Name: ACUITY X4 SPIRAL S
• 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: 15725250
• MDR Text Key: 303042697
• Report Number: 2124215-2022-45250
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526524554
• UDI-Public: 00802526524554
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

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: 04/13/2024
• Device Model Number: 4674
• Device Catalogue Number: 4674
• Device Lot Number: 877199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 12/06/2022
• Supplement Dates FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2022
• 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: 80 YR
• Patient Sex: Female