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

Model Number	D001
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implantable cardioverter defibrillator (icd) displayed code 1007 indicative of charge times exceeding limitations and was not responding to telemetry.The physician was considering device replacement.It was stated that the patient's health was possibly too critical to tolerate a replacement procedure.The patient was hospitalized for a different issue, needed dialysis, and was disabled to a certain extent.Additional information is being requested, but was unavailable at the time of this report.
Event or Problem Description
It was reported that the implantable cardioverter defibrillator (icd) displayed code 1007 indicative of charge times exceeding limitations and was not responding to telemetry.The physician was considering device replacement.It was stated that the patient's health was possibly too critical to tolerate a replacement procedure.The patient was hospitalized for a different issue, needed dialysis, and was disabled to a certain extent.It was additionally reported that the patient expired due to their underlying disease, in therapy-refractory cardiogenic shock.No additional information was obtained.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, an evaluation of the device was performed.Visual inspection noted no anomalies and x-ray inspection did not reveal any irregularities.It was observed that the device had no telemetry and no pacing output.The battery was isolated from the circuit for testing and the results of the battery analysis yielded no findings.The reported event (no telemetry, no output) was confirmed; however, the cause of the reported event could not be determined as the device functioned normally after power was applied.
Event or Problem Description
It was reported that the implantable cardioverter defibrillator (icd) displayed code 1007 indicative of charge times exceeding limitations and was not responding to telemetry.The physician was considering device replacement.It was stated that the patient's health was possibly too critical to tolerate a replacement procedure.The patient was hospitalized for a different issue, needed dialysis, and was disabled to a certain extent.It was additionally reported that the patient expired due to their underlying disease, in therapy-refractory cardiogenic shock.No additional information was obtained.

• Brand Name: ORIGEN MINI ICD VR
• Common Device Name: IMPLANTABLE DEVICE
• 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: 14131864
• Report Number: 2124215-2022-11292
• Device Sequence Number: 19440005
• Product Code: LWS
• UDI-Device Identifier: 00802526533723
• UDI-Public: 00802526533723
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/13/2023

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: 07/02/2017
• Device Model Number: D001
• Device Catalogue Number: D001
• Device Lot Number: 102456
• 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: 02/10/2022
• Supplement Date Received by Manufacturer: 05/30/2022; 06/16/2023
• Initial Report FDA Received Date: 04/16/2022
• Supplement Report FDA Received Date: 06/23/2022; 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Unknown