MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN EL ICD DR; IMPLANTABLE DEVICE

Model Number D143

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Atrial Tachycardia (1731)

Event Date 03/17/2019

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) delivered inappropriate shocks for supraventricular tachycardia (svt).The shock therapy did not convert the svt and resulted in exhaustion of tachycardia therapy.Boston scientific technical services (ts) discussed the rhythm identification algorithm.Available information indicates this product remains implanted and in service.No adverse patient effects were reported.

• Brand Name: INOGEN EL ICD DR
• Type of Device: IMPLANTABLE DEVICE
• 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: 8718297
• MDR Text Key: 148653978
• Report Number: 2124215-2019-10246
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526534263
• UDI-Public: 00802526534263
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/12/2016
• Device Model Number: D143
• Device Catalogue Number: D143
• Device Lot Number: 197471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2014
• 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 Age: 77 YR