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

Model Number	D011
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that fault code 1007 appeared for the device.The device and leads remain in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that fault code 1007 appeared for the device.The device was replaced and returned to boston scientific for analysis.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, visual inspection of the device identified tool marks on the device case, but no further anomalies.Review of device memory found a shorted lead error had been recorded.Memory also showed that after three shocks had been attempted and resulted in abnormal shock impedance measurements, the device battery status moved to end of life (eol).An x-ray of the device revealed that the internal high voltage fuse was damaged (i.E., no longer intact).The damage to the fuse most likely occurred during delivery of the shock that resulted in the shorted lead error.The damage to the high voltage fuse prevented any subsequent charging of the high voltage capacitors and delivery of shock therapy.As a result, the third high voltage charge attempt caused the device to declare eol because it could not successfully complete charging within 30 seconds, despite the fact that significant battery voltage and capacity remained.Analysis concluded this device was damaged when it attempted to deliver a shock via a shorted defibrillation lead.
Event or Problem Description
It was reported that fault code 1007 appeared for the device.The device was replaced and returned to boston scientific for analysis.No additional adverse patient effects were reported.

• Brand Name: INOGEN 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: 12215542
• Report Number: 2124215-2021-15537
• Device Sequence Number: 14170799
• Product Code: LWS
• UDI-Device Identifier: 00802526533808
• UDI-Public: 00802526533808
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• 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,Followup
• Report Date (Section B): 06/01/2022

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: 10/09/2020
• Device Model Number: D011
• Device Catalogue Number: D011
• Device Lot Number: 109315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 06/25/2021; 05/12/2022
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 08/04/2021; 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2018
• 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 Sex: Female