MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)

Model Number G247

Device Problems High impedance (1291); Loose or Intermittent Connection (1371); Patient-Device Incompatibility (2682)

Patient Problem Hematoma (1884)

Event Date 11/12/2019

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 the patient with this cardiac resynchronization therapy defibrillator (crt-d) developed a hematoma and the pocket had to be evacuated.While the pocket was opened, the left ventricular (lv) lead showed high out of range pacing impedance measurements of greater than 3000 ohms.Prior to pocket manipulation the impedance measurement was 1038 ohms.It was noted that the physician only disconnected the right ventricular (rv) lead and not the lv lead.Fluoroscopy showed the lead to be in the same position.Boston scientific technical services (ts) discussed possible causes including fracture and connection.The physician disconnected the lv lead and reconnected it with in range impedance measurements.The crt-d and lv lead remain in service and no additional adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation noted evidence indicating difficulty may have been encountered fully inserting a is-4 lead into the header of this device resulting in high impedance measurements.Please refer to the description for more information regarding the specific circumstances of this event.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) developed a hematoma and the pocket had to be evacuated.While the pocket was opened, the left ventricular (lv) lead showed high out of range pacing impedance measurements of greater than 3000 ohms.Prior to pocket manipulation the impedance measurement was 1038 ohms.It was noted that the physician only disconnected the right ventricular (rv) lead and not the lv lead.Fluoroscopy showed the lead to be in the same position.Boston scientific technical services (ts) discussed possible causes including fracture and connection.The physician disconnected the lv lead and reconnected it with in range impedance measurements.The crt-d and lv lead remain in service and no additional adverse patient effects were reported.

• Brand Name: VIGILANT X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 9549947
• MDR Text Key: 173710695
• Report Number: 2124215-2019-25950
• 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
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 222391
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR