MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G247

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Twiddlers Syndrome (2114)

Event Date 10/16/2018

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that this patient experienced twiddlers syndrome.As result, an implanted lead dislodged.A surgical revision was performed in which the dislodged lead and this cardiac resynchronization therapy defibrillator (crt-d) were extracted and replaced to resolve the issue.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, the device was thoroughly inspected and analyzed.Past experience suggests patient manipulation of the device through the skin (twiddler's syndrome) was the contributing factor to the clinical observations.

Event Description

It was reported that this patient experienced twiddlers syndrome.As result, an implanted lead dislodged.A surgical revision was performed in which the dislodged lead and this cardiac resynchronization therapy defibrillator (crt-d) were extracted and replaced to resolve the issue.

• Brand Name: VIGILANT X4 CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8314553
• MDR Text Key: 135344388
• Report Number: 2124215-2018-64304
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589287
• UDI-Public: 00802526589287
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/26/2020
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 196880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Date Manufacturer Received: 03/07/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 75 YR