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

Model Number	D013
Medical Device Problem Codes	Premature Discharge of Battery (1057); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
Boston scientific received information that this implantable cardioverter defibrillator's (icd) battery rapidly depleted.This device was explanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the device was thoroughly inspected and analyzed.External visual inspection identified minor scratches on the case and header that likely occurred during explant.Review of device memory confirmed that the device had reached elective replacement indicator (eri) status due to long charge times.The case was opened and the device was attached to an external coil, the charging frequency was measured and determined at half of the normal frequency.This indicates that the diode component connection is open.This incomplete electrical pathway within the devices shock charging circuitry resulted in the lengthened charge times that triggered eri.Despite exhibiting extended charge times, the maximum shock energy was still available and therapy availability is not compromised in devices exhibiting this issue.Therapy would have been available to the patient if required, albeit with a somewhat longer charge time.This intermittent connection manifests during capacitor reformations or therapy charges, and was confirmed as the root cause for the device triggering eri.
Event or Problem Description
Supplemental report is being submitted with analysis results.

• 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: 8053884
• Report Number: 2124215-2018-61620
• Device Sequence Number: 11289165
• Product Code: LWS
• UDI-Device Identifier: 00802526533846
• UDI-Public: 00802526533846
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2018

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: 04/16/2016
• Device Model Number: D013
• Device Catalogue Number: D013
• Device Lot Number: 101097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2018
• Initial Date Received by Manufacturer: 09/29/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 15 YR