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

Model Number D011

Device Problems Failure to Convert Rhythm (1540); Unintended Electrical Shock (4018)

Patient Problems Syncope (1610); Ventricular Fibrillation (2130)

Event Date 11/13/2019

Event Type  Injury  

Event Description

It was reported that this patient went into ventricular tachycardia, after dialysis, and coded.A device check revealed that the patient received anti-tachycardia pacing (atp) in the lower zones and this therapy accelerated the patient into ventricular fibrillation.Eight shocks were delivered, which exhausted therapy.The last shock converted the arrhythmia, but it was reported that chest compressions were performed.The patient was hospitalized and is now stable.No additional adverse patient effects were reported.This product remains in service.This report will be updated, should additional information be received.

• Brand Name: INOGEN MINI ICD VR
• Type of Device: 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: 9550878
• MDR Text Key: 173703700
• Report Number: 2124215-2020-00074
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526533808
• UDI-Public: 00802526533808
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960040/S306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/04/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/19/2016
• Device Model Number: D011
• Device Catalogue Number: D011
• Device Lot Number: 437028
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 01/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 76 YR