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

Model Number	D012
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) device is exhibiting potential premature battery depletion behavior.Boston scientific technical services (ts) indicated that the device recently reached explant indicator status due to a capacitor charge time of 16.2 seconds.Ts noted that the device will still have a 90 day replacement window but they could consider replacing the device sooner due to the extended charge time.Ts offered to perform an analysis of device data, but the healthcare provider stated they will inform the physician and go from there.The device remains in-service at this time.No adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) device is exhibiting potential premature battery depletion behavior.Boston scientific technical services (ts) indicated that the device recently reached explant indicator status due to a capacitor charge time of 16.2 seconds.Ts noted that the device will still have a 90 day replacement window but they could consider replacing the device sooner due to the extended charge time.Ts offered to perform an analysis of device data, but the healthcare provider stated they will inform the physician and go from there.The device remains in-service at this time.No adverse patient effects were reported.Additional information was received that this icd device was subsequently explanted and replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Information indicates this device is currently in the possession of the explanting hospital.This investigation will be updated should further information be provided.
Additional Manufacturer Narrative
Information indicates this device is currently in the possession of the explanting hospital.This investigation will be updated should further information be provided.The returned implantable cardioverter defibrillator (icd) device was analyzed upon receipt at our post market quality assurance laboratory.An engineering-level longevity prediction calculation was completed to assess the rate of battery depletion.Given the programmed parameters and other data stored within the memory of the device, the results of this calculation indicated that the actual rate of battery depletion fell within an acceptable range.Next, a series of diagnostic tests were conducted that verified the performance of pacing, sensing, defibrillation, and recording functions.Having met the engineering longevity prediction, functionally passed all returned product testing, and with no further information to indicate a product performance issue, we have concluded that this device experienced normal battery depletion.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) device is exhibiting potential premature battery depletion behavior.Boston scientific technical services (ts) indicated that the device recently reached explant indicator status due to a capacitor charge time of 16.2 seconds.Ts noted that the device will still have a 90 day replacement window but they could consider replacing the device sooner due to the extended charge time.Ts offered to perform an analysis of device data, but the healthcare provider stated they will inform the physician and go from there.The device remains in-service at this time.No adverse patient effects were reported.Additional information was received that this icd device was subsequently explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: INOGEN MINI ICD DR
• Common Device Name: 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: 15722228
• Report Number: 2124215-2022-45208
• Device Sequence Number: 14171365
• Product Code: LWS
• UDI-Device Identifier: 00802526533822
• UDI-Public: 00802526533822
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2023

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: 08/27/2016
• Device Model Number: D012
• Device Catalogue Number: D012
• Device Lot Number: 104457
• 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: 10/25/2022
• Supplement Date Received by Manufacturer: 11/23/2022; 05/11/2023
• Initial Report FDA Received Date: 11/03/2022
• Supplement Report FDA Received Date: 11/30/2022; 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2014
• 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: Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male