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

Model Number	D013
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/29/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that pacing impedances on the non-boston scientific lead(s) connected to this device were intermittently high out of range.The patient reportedly required open-heart surgery for a non-device related reason and the physician elected to explant and replace the patient's implantable cardioverter defibrillator (icd) and leads during the procedure.No additional adverse patient effects were reported.
Additional 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 or Problem Description
It was reported that pacing impedances on the non-boston scientific lead(s) connected to this device were intermittently high out of range.The patient reportedly required open-heart surgery for a non-device related reason and the physician elected to explant and replace the patient's implantable cardioverter defibrillator (icd) and leads during the procedure.No additional adverse patient effects were reported.Additional information was received for review of this mini-implantable cardioverter defibrillator (icd) due to unrelated patient symptoms, which determined that the device was functioning as programmed.It appears that instead of explanting and replacing the system while in for previously reported unrelated open heart surgery, they decided to program tachy therapy off and have the device function as a pacemaker only.This icd 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: 8719629
• Report Number: 2124215-2019-11354
• Device Sequence Number: 1844512
• Product Code: LWS
• UDI-Device Identifier: 00802526533846
• UDI-Public: 00802526533846
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/05/2016
• Device Model Number: D013
• Device Catalogue Number: D013
• Device Lot Number: 100372
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 11/01/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 61 YR