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

Model Number	D002
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.A request was made to have data from this device analyzed.Data analysis showed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.This device was replaced and is expected to be returned for analysis.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
At this time, the product has not been returned.If the product is returned, analysis will be performed, and this report would be updated should information be provided at that time.
Additional Manufacturer Narrative
Supplemental: the product has been received for analysis.This report will be updated upon completion of analysis.Initial: at this time, the product has not been returned.If the product is returned, analysis will be performed, and this report would be updated should information be provided at that time.
Event or Problem Description
It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.A request was made to have data from this device analyzed.Data analysis showed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.This device was replaced and returned for analysis.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.A request was made to have data from this device analyzed.Data analysis showed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.This device was replaced and returned for analysis.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Supplemental 2: 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.Supplemental: the product has been received for analysis.This report will be updated upon completion of analysis.Initial: at this time, the product has not been returned.If the product is returned, analysis will be performed, and this report would be updated should information be provided at that time.

• Brand Name: ORIGEN MINI ICD DR
• 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: 13444779
• Report Number: 2124215-2021-40977
• Device Sequence Number: 19360610
• Product Code: LWS
• UDI-Device Identifier: 00802526533747
• UDI-Public: 00802526533747
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2022

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: 08/11/2017
• Device Model Number: D002
• Device Catalogue Number: D002
• Device Lot Number: 107012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 03/04/2022; 09/14/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 04/21/2022; 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2015
• 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 Age: 56 YR
• Patient Sex: Male