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

Model Number	D013
Medical Device Problem Codes	Telemetry Discrepancy (1629); Inappropriate or Unexpected Reset (2959); Interrogation Problem (4017)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Date of Event	08/08/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No additional information is available.If additional information becomes available the report will be updated at that time.
Event or Problem Description
It was reported that the remote home monitor was experiencing difficulty interrogating the implantable cardioverter defibrillator (icd).At first a new remote home monitor was sent to the patient, however the issue persisted.The patient's home environment was ruled out and the patient was referred to the clinic.During the in clinic visit the field representative experienced difficulty establishing telemetry with the icd.A disk of the device's memory was sent in for review.Upon review, engineering found a radio frequency hardware timeout had occurred five years earlier.Engineering noted that this indicates an issue within the rf telemetry hardware and was determined to be the likely cause of the interrogation issues seen within the field.Consideration of device replacement was discussed.At this time the icd remains in service and no adverse patient effects were reported.
Event or Problem Description
This device was recently explanted due to normal battery depletion and return for analysis.
Additional Manufacturer Narrative
No additional information is available.If additional information becomes available the report will be updated at that time.The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 9100175
• Report Number: 2124215-2019-17618
• Device Sequence Number: 19488556
• Product Code: LWS
• UDI-Device Identifier: 00802526533846
• UDI-Public: 00802526533846
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2022

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: 06/12/2016
• Device Model Number: D013
• Device Catalogue Number: D013
• Device Lot Number: 102157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male