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

Model Number	D013
Medical Device Problem Codes	High impedance (1291); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Ventricular Tachycardia (2132)
Date of Event	11/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As no further information concerning this report is expected at this time, our investigation is complete.This investigation will be updated should further information be provided.
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) experienced a ventricular tachycardia (vt) storm.Upon interrogation an error code 1005 was discovered indicating that there were shock impedances greater than 145 ohms.The patient's right ventricular (rv) lead is a non-boston scientific product.Boston scientific technical services (ts) suggested evaluation of icd and rv lead system.No adverse patient effects were reported.Additional information was received that this patient has had subsequent shocks which have all been appropriate and successful.The shock impedances were all within normal limits.The patient has been referred for a vt study.This product remains in-service.

• Brand Name: INOGEN MINI ICD DR
• Common Device Name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8112669
• Report Number: 2124215-2018-61879
• Device Sequence Number: 2165859
• Product Code: LWS
• UDI-Device Identifier: 00802526533846
• UDI-Public: 00802526533846
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/11/2017
• Device Model Number: D013
• Device Catalogue Number: D013
• Device Lot Number: 245595
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 11/28/2018
• Patient Sequence Number: 1
• Patient Age: 59 YR