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

Model Number	D013
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	11/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No additional information is available.If additional information becomes available the report will be updated at that time.
Event or Problem Description
It was reported that the implantable cardioverter defibrillator (icd) showed nine months remaining and one month later the battery status showed the explant indicator.Engineering analysis found that elective replacement indicator (eri) was set due to two charge times of greater than 15 seconds.Further review found that the device is high rate atrial sensing at an average rate of 342 bpm.High rate atrial sensing can cause an increase in power consumption.This increase in power consumption may have contributed to the long capacitor charge times and shorter than expected longevity.It was noted that the icd should have enough power for the full 90 day replacement period, however boston scientific technical services (ts) noted that the capacitor charge times may be greater than 15 seconds.At this time the icd remains in service and no adverse patient effects were reported.
Event or Problem Description
This report is being filed to submit the analysis results.
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.Patient code 3191 captures the reportable event of surgery.
Additional Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.Patient code 3191 captures the reportable event of surgery.
Event or Problem Description
Additional information was received that the implantable cardioverter defibrillator (icd) was 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
• MDR Report Key: 9550888
• Report Number: 2124215-2019-27129
• Device Sequence Number: 438583
• Product Code: LWS
• UDI-Device Identifier: 00802526533846
• UDI-Public: 00802526533846
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2020

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: 07/30/2016
• Device Model Number: D013
• Device Catalogue Number: D013
• Device Lot Number: 102743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Received by Manufacturer: 12/02/2019
• Supplement Date Received by Manufacturer: 01/07/2020; 07/23/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 04/06/2020; 09/25/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR