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

Model Number	D010
Medical Device Problem Codes	Failure to Convert Rhythm (1540); Inaccurate Synchronization (1609)
Health Effect - Clinical Code	Ventricular Fibrillation (2130)
Date of Event	11/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient experienced ventricular tachycardia (vt).This implantable cardioverter defibrillator (icd) delivered anti-tachycardia pacing (atp) and one 41 joule shock.After the shock, the patient's rhythm accelerated to ventricular fibrillation (vf).The next seven shocks failed to convert the rhythm and therapy was exhausted.This patient was hospitalized and required external defibrillation.Technical services (ts) analyzed device episode data and recommended a dual coil tachy lead.It was noted that defibrillation threshold (dft) test was performed successfully.No additional adverse patient effects were reported.Currently, this icd remains in service.
Event or Problem Description
It was reported that this patient experienced ventricular tachycardia (vt).This implantable cardioverter defibrillator (icd) delivered anti-tachycardia pacing (atp) and one 41 joule shock.After the shock, the patient's rhythm accelerated to ventricular fibrillation (vf).The next seven shocks failed to convert the rhythm and therapy was exhausted.This patient was hospitalized and required external defibrillation.Technical services (ts) analyzed device episode data and recommended a dual coil tachy lead.It was noted that defibrillation threshold (dft) test was performed successfully.No additional adverse patient effects were reported.Currently, this icd remains in service.
Additional Manufacturer Narrative
After medical review it was determined to add code for life-threatening event that required external intervention.

• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 15833509
• Report Number: 2124215-2022-48115
• Device Sequence Number: 12110139
• Product Code: LWS
• UDI-Device Identifier: 00802526533785
• UDI-Public: 00802526533785
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/24/2017
• Device Model Number: D010
• Device Catalogue Number: D010
• Device Lot Number: 206671
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/04/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2015
• 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: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male