MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN X4 CRT-D; IMPLANTED DEVICE

Model Number G158

Device Problem Difficult to Insert (1316)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been returned for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that during a scheduled left ventricular (lv) lead replacement procedure, the terminal end of the newly implanted lv lead did not fit in the device header of this existing cardiac resynchronization therapy defibrillator (crt-d) device.As a result, the device was explanted and replaced during the same procedure.No additional adverse patient effects were reported.

Manufacturer Narrative

Patient code 3191 captures the reportable event of surgery.The device has been returned for analysis.This report will be updated upon completion of analysis.The associated investigation noted evidence indicating difficulty may have been encountered fully inserting a left ventricular (lv) is-1 lead into the header of this device with an is-4 lv connector port.Please refer to the description for more information regarding the specific circumstances of this event.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header noted dried blood in the lv set screw terminal block area and in the lv lead barrel.There is a hole in the lv seal plug and the right atrial (ra) and right ventricular (rv) seal plugs are intact.The set screws operate normally.As part of additional testing, a lv lead with an is-4 terminal connector was inserted into the device lv port.The lead was easily and completely inserted.The set screw was tightened and held the lead in place.The device has normal battery voltage and the batter status is beginning of life (bol).A review of device memory noted no fault cades.A series of electrical tests were also performed, and normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

Event Description

It was reported that during a scheduled left ventricular (lv) lead replacement procedure, the terminal end of the newly implanted lv lead did not fit in the device header of this existing cardiac resynchronization therapy defibrillator (crt-d) device.As a result, the device was explanted and replaced during the same procedure.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN X4 CRT-D
• Type of Device: IMPLANTED DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10620781
• MDR Text Key: 209609869
• Report Number: 2124215-2020-18021
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534904
• UDI-Public: 00802526534904
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/23/2021
• Device Model Number: G158
• Device Catalogue Number: G158
• Device Lot Number: 221152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Date Manufacturer Received: 03/29/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR