MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN EL ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number D152

Device Problems Failure to Capture (1081); Over-Sensing (1438)

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

Event Date 03/20/2023

Event Type  malfunction  

Event Description

It was reported that this implantable cardioverter defibrillator (icd) exhibited suspected loss of capture (loc) on the right atrial (ra) lead.Further testing was recommended by boston scientific technical services (ts).Upon review, a signal artifact monitor (sam) episode was noted that resulted in the minute ventilation (mv) feature disabled.Additional information was received that a lead fracture was confirmed and the ra lead was explanted and replaced.This device was explanted due to therapy upgrade.No 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.Investigation of the available information determined this device exhibited oversensing of noise generated by the minute ventilation (mv) sensor that is related to a high impedance condition.Please see the description for more information regarding the specific circumstances of this event.

• Brand Name: DYNAGEN EL ICD DR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16802449
• MDR Text Key: 313923382
• Report Number: 2124215-2023-19643
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526534324
• UDI-Public: 00802526534324
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960040/S306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/11/2019
• Device Model Number: D152
• Device Catalogue Number: D152
• Device Lot Number: 538584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male