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

Model Number	D011
Medical Device Problem Codes	High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	07/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient implanted with this implantable cardioverter defibrillator (icd) system had received numerous shocks.Upon interrogation, this right ventricular (rv) defibrillation lead and icd had recorded a code 1005, indicative of an open circuit condition detected upon shock delivery due to a high out-of-range shock impedance measurement greater than 145 ohms.The patient received at least 12 shocks on (b)(6) 2023, as interrogation revealed the code 1005 message on the programmer screen 12 times.It was not possible to view episodes to assess whether therapy was appropriate and/or exhausted, as the icd had reached end of life (eol) on (b)(6) 2023.Technical services (ts) reviewed troubleshooting options.This icd system remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient implanted with this implantable cardioverter defibrillator (icd) system had received numerous shocks.Upon interrogation, this right ventricular (rv) defibrillation lead and icd had recorded a code 1005, indicative of an open circuit condition detected upon shock delivery due to a high out-of-range shock impedance measurement greater than 145 ohms.The patient received at least 12 shocks on july 27, 2023, as interrogation revealed the code 1005 message on the programmer screen 12 times.It was not possible to view episodes to assess whether therapy was appropriate and/or exhausted, as the icd had reached end of life (eol) on april 28, 2023.Technical services (ts) reviewed troubleshooting options.This icd system remains in service.No additional adverse patient effects were reported.It was reported that this implantable cardioverter defibrillator (icd) and right ventricular (rv) lead were explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: INOGEN MINI ICD VR
• 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: 17506292
• Report Number: 2124215-2023-42921
• Device Sequence Number: 15028407
• Product Code: LWS
• UDI-Device Identifier: 00802526533808
• UDI-Public: 00802526533808
• 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: 2016
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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: 05/02/2016
• Device Model Number: D011
• Device Catalogue Number: D011
• Device Lot Number: 436749
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2023
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Age: 42 YR
• Patient Sex: Male