MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN EL ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number D152

Device Problems No Audible Alarm (1019); Noise, Audible (3273); Interrogation Problem (4017)

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

Event Date 02/05/2023

Event Type  Injury  

Manufacturer Narrative

The product has been received for analysis.Upon completion of the analysis of the compliant device, if there is any further relevant information from that review, a supplemental report will be filed.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) was difficult to interrogate.Additionally, it was noted that the patient with this icd heard beep tones.The patient was brought to the clinic, and the health care provider applied a magnet, but they did not hear any beeping tone, magnet response was not verified.Device replacement was recommended.Subsequently, a revision procedure was performed and the icd was explanted and replaced.No additional adverse patient effects were reported.

Manufacturer Narrative

This device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Although the device memory diagnostics demonstrated that the daily battery voltage measurements displayed an irregular pattern of discharge, the battery voltage level upon receipt in the laboratory remained sufficient to ensure therapy availability/delivery while the device was implanted.Using historical daily battery voltage measurement data, engineers determined that this device was demonstrating behavior consistent with a latent current leakage path within the battery itself, which resulted in a partial depletion of the battery.This behavior is caused by a latent electrical leakage path that develops over time between the anode and cathode within the device battery.In certain circumstances, lithium metal ions can re-plate to form clusters that may result in an internal current leakage.A design enhancement was implemented in 2013 to enlarge the physical barrier between the electrode layers to prevent current leakage in the area of the battery that is most often affected by this behavior.The product has been received for analysis.Upon completion of the analysis of the compliant device, if there is any further relevant information from that review, a supplemental report will be filed.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) was difficult to interrogate.Additionally, it was noted that the patient with this icd heard beep tones.The patient was brought to the clinic, and the health care provider applied a magnet, but they did not hear any beeping tone, magnet response was not verified.Device replacement was recommended.Subsequently, a revision procedure was performed and the icd was explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN EL ICD DR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 16435285
• MDR Text Key: 310140639
• Report Number: 2124215-2023-08676
• 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,Followup
• Report Date: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/22/2018
• Device Model Number: D152
• Device Catalogue Number: D152
• Device Lot Number: 516787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2016
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male