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

Model Number G447

Device Problems Connection Problem (2900); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2021

Event Type  Injury  

Event Description

It was reported that during a left ventricular (lv) lead implant procedure, this physician noted a detached set screw from the device header when attempting to connect the lv lead.The physician elected to surgically explant and replace the device to resolve the event.The patient was stable with no additional adverse consequences.The device was received for analysis and is pending analysis completion.

Event Description

It was reported that during a left ventricular (lv) lead implant procedure, this physician noted a detached set screw from the device header when attempting to connect the lv lead.The physician elected to surgically explant and replace the device to resolve the event.The patient was stable with no additional adverse effects reported.The device was received for analysis.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.The lv set screw was found stuck in the returned non-boston scientific hex wrench.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.It was concluded that the use of a non-boston scientific hex wrench contributed to the clinical observations.

• Brand Name: RESONATE 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: 11668702
• MDR Text Key: 245492758
• Report Number: 2124215-2021-07383
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/05/2021

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: 09/27/2022
• Device Model Number: G447
• Device Catalogue Number: G447
• Device Lot Number: 246614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 04/14/2021
• Supplement Dates Manufacturer Received: 04/29/2021
• Supplement Dates FDA Received: 07/05/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention