MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN EL ICD VR; IMPLANTABLE DEVICE

Model Number D151

Device Problems Premature Discharge of Battery (1057); Noise, Audible (3273); Interrogation Problem (4017)

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

Event Date 03/10/2023

Event Type  Injury  

Event Description

It was reported that this implantable cardioverter defibrillator (icd) was unable to be interrogated.Technical services was contacted and provided troubleshooting options.No magnet response was found.Technical services recommended replacing the device.At this time, the device remains in service.No adverse patient effects were reported.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) was unable to be interrogated.Technical services was contacted and provided troubleshooting options.No magnet response was found.Technical services recommended replacing the device.At this time, the device remains in service.No adverse patient effects were reported.This supplemental report is being filed as additional information was received which reported that the patient with this implantable cardioverter defibrillator (icd) heard beeping tones for four days straight.Subsequently, the device was explanted and replaced due to the device exhibiting premature battery depletion.No additional adverse patient effects were reported.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) was unable to be interrogated.Technical services was contacted and provided troubleshooting options.No magnet response was found.Technical services recommended replacing the device.At this time, the device remains in service.No adverse patient effects were reported.This supplemental report is being filed as additional information was received which reported that the patient with this implantable cardioverter defibrillator (icd) heard beeping tones for four days straight.Subsequently, the device was explanted and replaced due to the device exhibiting premature battery depletion.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.External visual inspection of the device revealed no anomalies.The device case was then opened to facilitate analysis of the internal components.The battery was separated from the other device electronics and the overall current draw of the circuitry was measured.A normal current drain was observed within the circuitry.Collectively, the pattern of irregular daily battery voltage measurements in conjunction with normal power levels and device hybrid current draw is consistent with behavior of devices where a latent current leakage path has occurred within the battery itself, resulting 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.

• Brand Name: DYNAGEN EL ICD VR
• Type of Device: IMPLANTABLE DEVICE
• 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: 16712523
• MDR Text Key: 313016483
• Report Number: 2124215-2023-16768
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526534300
• UDI-Public: 00802526534300
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/30/2017
• Device Model Number: D151
• Device Catalogue Number: D151
• Device Lot Number: 189506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male