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

Model Number	D001
Medical Device Problem Codes	Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that error code 1007 and 1003 were displayed since the last device follow up.A review of the device data by technical services (ts) noted that the since the device had triggered end of life (eol) there was little diagnostic data.Ts confirmed the error codes and noted that fault code 1007 indicated that the capacitor charge time was exceeded.The last capacitor reform was (b)(6) 2021 and the charge time exceeded 45 seconds, after which the device aborts further charging.Ts also noted that since the device triggering fc1003 the battery was depleting more quickly than expected.Immediate device replacement was recommended.The device remains implanted.The patient remained hospitalized and no further adverse patient effects were reported.
Additional Manufacturer Narrative
The device remains implanted.Should additional information become available this investigation will be updated.
Event or Problem Description
It was reported that error code 1007 and 1003 were displayed since the last device follow up.A review of the device data by technical services (ts) noted that the since the device had triggered end of life (eol) there was little diagnostic data.Ts confirmed the error codes and noted that fault code 1007 indicated that the capacitor charge time was exceeded.The last capacitor reform was march 15, 2021 and the charge time exceeded 45 seconds, after which the device aborts further charging.Ts also noted that since the device triggering fc1003 the battery was depleting more quickly than expected.Immediate device replacement was recommended.Additional information noted that at the last telemetry follow up in march 2022 it was not possible to estimate the battery due to alleged battery depletion.The device was explanted, replaced, and is pending a return.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
The device was planned to be returned.Should the device be returned analysis will be performed and this investigation will be updated.
Event or Problem Description
It was reported that error code 1007 and 1003 were displayed since the last device follow up.A review of the device data by technical services (ts) noted that the since the device had triggered end of life (eol) there was little diagnostic data.Ts confirmed the error codes and noted that fault code 1007 indicated that the capacitor charge time was exceeded.The last capacitor reform was (b)(6) 2021 and the charge time exceeded 45 seconds, after which the device aborts further charging.Ts also noted that since the device triggering fc1003 the battery was depleting more quickly than expected.Immediate device replacement was recommended.Additional information noted that at the last telemetry follow up in march 2022 it was not possible to estimate the battery due to alleged battery depletion.The device was explanted, replaced, and was received for analysis.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
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.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: ORIGEN 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: 14069122
• Report Number: 2124215-2022-08336
• Device Sequence Number: 4766092
• Product Code: LWS
• UDI-Device Identifier: 00802526533723
• UDI-Public: 00802526533723
• Combination Product (Y/N): N
• Initial Reporter Country: BK
• PMA/510(K) Number: P960040/S306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2023

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: 04/30/2017
• Device Model Number: D001
• Device Catalogue Number: D001
• Device Lot Number: 102118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2022
• Supplement Date Received by Manufacturer: 04/13/2022; 04/27/2023
• Initial Report FDA Received Date: 04/10/2022
• Supplement Report FDA Received Date: 05/25/2022; 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male