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

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	07/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) showed error codes 1004 and 1007, and the device was operating in safety mode.The device was explanted and replaced.No additional adverse patient effects were reported.The explanted device was expected to be returned for analysis.Technical services discussed the error codes were for a shock into a shorted condition (1004) and charge time out (1007).
Additional Manufacturer Narrative
The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.Upon receipt at our post market quality assurance laboratory, visual inspection of the device identified an arc mark on the device case.Review of device memory confirmed a shorted lead error (code 1004) was recorded on 15 june 2022 after a shock was attempted.The device battery status moved to end of life (eol) due to long charge times (code 1007).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 shock 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 subsequent 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.Evidence indicates the associated rv lead was damaged and when this device attempted to deliver a shock through the lead, a short was detected.This device operated as designed in the presence of a shorted defibrillation lead.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) showed error codes 1004 and 1007, and the device was operating in safety mode.The device was explanted and replaced.No additional adverse patient effects were reported.The explanted device was expected to be returned for analysis.Technical services discussed the error codes were for a shock into a shorted condition (1004) and charge time out (1007).

• Brand Name: INOGEN MINI ICD VR
• 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: 15242629
• Report Number: 2124215-2022-31061
• Device Sequence Number: 6304720
• Product Code: LWS
• UDI-Device Identifier: 00802526533808
• UDI-Public: 00802526533808
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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: 08/20/2020
• Device Model Number: D011
• Device Catalogue Number: D011
• Device Lot Number: 108961
• 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: 07/26/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown