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

Model Number	D013
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that that patient's communicator displayed a red call doctor (rcd) icon, which indicates a potential issue with their implantable cardioverter defibrillator (icd).Boston scientific technical services (ts) referred the patient to their following physician.A remote interrogation was performed and the right atrial (ra) lead and right ventricular (rv) lead exhibited out-of-range (oor) pacing impedances.The patient's ra and rv leads were non-boston scientific products.This icd system remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent impedance measurements with no objective evidence of a malfunction or inadequate lead-to-device connection; please refer to the description for more information regarding the specific circumstances of this event.
Event or Problem Description
This supplemental report is being filed as the conclusion code was updated.

• 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: 9147444
• Report Number: 2124215-2019-19888
• Device Sequence Number: 2664898
• Product Code: LWS
• UDI-Device Identifier: 00802526533846
• UDI-Public: 00802526533846
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2020

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: 04/24/2016
• Device Model Number: D013
• Device Catalogue Number: D013
• Device Lot Number: 101355
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR