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	12/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been received for analysis.This report will be updated upon completion of analysis.(b)(4).
Event or Problem Description
It was reported that the implantable cardioverter defibrillator (icd) battery remaining was at three and a half years and there was concern over possible early depletion.Engineering analysis found that the device was depleting earlier than expected due to longer than expected charge times that exceeded the elective replacement indicator (eri) limit.Subsequently the icd was explanted and replaced.No additional adverse patient effects were reported.
Event or Problem Description
This report is being filed to submit the analysis results.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, the device was analyzed.A longevity calculation was performed, which confirmed that the battery voltage was lower than expected.The device case was opened and the battery was replaced with an external power supply.Electrical measurements noted a high current condition.Detailed testing of individual components found a compromised ceramic capacitor.This compromised capacitor resulted in the observed high power consumption and resultant premature battery depletion.Patient code 3191 captures the reportable event of surgery.
Additional Manufacturer Narrative
This report is being submitted to correct the patient code h6 field that was filed correctly on the first report, but inadvertently changed on the second most recent filed report.Patient code 3191 captures the reportable event of surgery.
Event or Problem Description
This report is being filed to correct information that was inadvertently incorrect on the last filed report.

• 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: 9624070
• Report Number: 2124215-2020-01251
• Device Sequence Number: 19517619
• Product Code: LWS
• UDI-Device Identifier: 00802526533846
• UDI-Public: 00802526533846
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 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): 08/03/2020

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: 07/07/2016
• Device Model Number: D013
• Device Catalogue Number: D013
• Device Lot Number: 102310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 05/12/2020; 06/04/2020
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 06/25/2020; 08/03/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 50 YR