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

Model Number	D021
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis showed that the battery diagnostics shows random, intermittent, unpredictable behavior, consistent with a device malfunction.Recommended device explant and replacement.Additional information received indicated that the device was explanted due to normal battery depletion (nbd).No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.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.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 was sufficient to ensure therapy availability/delivery while the device was implanted.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.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis showed that the battery diagnostics shows random, intermittent, unpredictable behavior, consistent with a device malfunction.Recommended device explant and replacement.Additional information received indicated that the device was explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN MINI ICD VR
• Common Device Name: 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: 16936326
• Report Number: 2124215-2023-24105
• Device Sequence Number: 5730985
• Product Code: LWS
• UDI-Device Identifier: 00802526533884
• UDI-Public: 00802526533884
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2024

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/08/2018
• Device Model Number: D021
• Device Catalogue Number: D021
• Device Lot Number: 105344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2023
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male