MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INOGEN MINI ICD VR; IMPLANTABLE ELECTRODE

Model Number	D011
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the battery of this implantable cardioverter defibrillator (icd) was suspected to be prematurely depleting.Technical services (ts) discussed the device charge time is a secondary indicator of elective replacement and recommended device replacement within the next ninety days.No adverse patient effects were reported.At this time, the device remains in service.

• Brand Name: INOGEN MINI ICD VR
• Common Device Name: IMPLANTABLE ELECTRODE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 12686467
• Report Number: 2124215-2021-31957
• Device Sequence Number: 1245793
• Product Code: LWS
• UDI-Device Identifier: 00802526533808
• UDI-Public: 00802526533808
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2021

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: 05/14/2016
• Device Model Number: D011
• Device Catalogue Number: D011
• Device Lot Number: 436893
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 10/22/2021
• Patient Sequence Number: 1
• Patient Age: 85 YR