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

Model Number	D011
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.This device remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.This device was explanted and returned for analysis.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.External visual inspection of the device revealed no anomalies.Review of the device memory confirmed that a low voltage alert was recorded.Although the device memory diagnostics demonstrated that the daily battery voltage measurements displayed an irregular pattern of discharge, the battery voltage level upon receipt in the laboratory was sufficient to ensure therapy availability/delivery while the device was implanted.The device case was then opened to facilitate analysis of the internal components.The battery was separated from the other device electronics and the overall current draw of the circuitry was measured.A normal current drain was observed within the circuitry.Collectively, the pattern of irregular daily battery voltage measurements in conjunction with normal power levels and device hybrid current draw is consistent with behavior of devices where a latent current leakage path has occurred within the battery itself, resulting in a partial depletion of the battery.

• Brand Name: INOGEN MINI ICD VR
• Common Device Name: IMPLANTABLE DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 11713404
• Report Number: 2124215-2021-05262
• Device Sequence Number: 3527475
• Product Code: LWS
• UDI-Device Identifier: 00802526533808
• UDI-Public: 00802526533808
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

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: 01/08/2018
• Device Model Number: D011
• Device Catalogue Number: D011
• Device Lot Number: 103389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention