MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT EL ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number D233

Device Problems Pocket Stimulation (1463); Migration (4003)

Patient Problems Device Overstimulation of Tissue (1991); Twiddlers Syndrome (4563)

Event Date 03/03/2022

Event Type  Injury  

Event Description

It was reported that the patient with this implantable cardioverter defibrillator (icd) felt that the device was kicking and needs replacement or at least fix the lead.Additional information from the field representative was obtained which indicated that the patient was experiencing cardiac stimulation and the chest-xray showed that the device was displaced with multiple rotations of leads indicating twiddler's syndrome.A system revision was performed.The device remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

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

• Brand Name: VIGILANT EL ICD DR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 14230335
• MDR Text Key: 290257727
• Report Number: 2124215-2022-13724
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526587801
• UDI-Public: 00802526587801
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960040/S385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/19/2023
• Device Model Number: D233
• Device Catalogue Number: D233
• Device Lot Number: 609857
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• 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; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female