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

Model Number	D011
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Unexpected Therapeutic Results (1631); Delayed Charge Time (2586)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	09/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) reverted to safety core mode unexpectedly.Technical services (ts) discussed device functionality and recommended device replacement due to limited therapy available in safety mode.Surgical intervention was undertaken.The icd was explanted and replaced with a new device.No additional adverse patient effects were reported.The device has not been received for analysis.If the device is returned, this report will be updated with pertinent information, upon completion of product analysis.

• 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
• MDR Report Key: 12660948
• Report Number: 2124215-2021-30142
• Device Sequence Number: 17263033
• Product Code: LWS
• UDI-Device Identifier: 00802526533808
• UDI-Public: 00802526533808
• 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: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2021

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: 08/05/2016
• Device Model Number: D011
• Device Catalogue Number: D011
• Device Lot Number: 437639
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/19/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR