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

Model Number G247

Device Problem Pocket Stimulation (1463)

Patient Problems Muscle Stimulation (1412); No Code Available (3191)

Event Date 02/14/2020

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 implanted with this cardiac resynchronization therapy defibrillator (crt-d) experienced diaphragmatic stimulation shortly after implant.The device was explanted and a new device was implanted.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, the device was forwarded to detailed analysis for further investigation.Analysis indicated that the allegation against the device was not confirmed.High power visual inspection of the header and lead barrels noted no irregularities and all seal plugs were intact.Review of memory noted no suspicious faults or resets.Automated diagnostic testing verified the performance of pacing, sensing, shocking and recording functions of the device commensurate with battery voltage.There was no problem detected.Patient code 3191 captures the reportable event of surgery.Correction to fields b2: outcomes attrib to adv event, f10: patient code and h6 patient code.

Event Description

It was reported that the patient with this cardiac resynchronization therapy defibrillator (crt-d) experienced phrenic nerve stimulation after implant.The device was explanted and a new device was implanted.No additional adverse patient effects were reported.

• 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: 9973358
• MDR Text Key: 188065573
• Report Number: 2124215-2020-08022
• Device Sequence Number: 1
• Product Code: NIK
• 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: 07/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/02/2021
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 230664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Date Manufacturer Received: 05/27/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR