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

Model Number D140

Device Problems Pocket Stimulation (1463); Device Displays Incorrect Message (2591)

Patient Problems Muscle Stimulation (1412); No Consequences Or Impact To Patient (2199)

Event Date 12/18/2018

Event Type  Injury  

Event Description

It was reported that the patient with this implantable cardioverter defibrillator (icd) presented to the hospital due to pocket stimulation.Upon interrogation, it was discovered that the device had entered safety mode.A revision procedure was performed and this icd was explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: INOGEN EL 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 CLONMEL LIMITED; cashel road; ,; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8300304
• MDR Text Key: 134848970
• Report Number: 2124215-2019-01601
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526534201
• UDI-Public: 00802526534201
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: P960040/S306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/19/2017
• Device Model Number: D140
• Device Catalogue Number: D140
• Device Lot Number: 191303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2015
• 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