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

Model Number	D001
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Summary of the investigation: with the available information, bsc cannot confirm the clinical observations due to lack of product return.Device history record review: a review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Device technical analysis: this device has not been returned; therefore, technical analysis cannot be conducted.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.Labeling review: review of labeling determined the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance to labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not required further review.Investigation conclusion: reported adverse event known and documented in the labeling (including both short or long term known complications or adverse reactions).
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited high out of range shock impedance measurement of greater than 150 ohms on the right ventricular (rv) lead channel.A lead revision procedure was scheduled.Additional information has been requested to the hospital regarding the event resolution, but no information was received.At this time, the device remains in service.There was no adverse patient effects were reported.

• 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
• MDR Report Key: 10311415
• Report Number: 2124215-2020-15142
• Device Sequence Number: 13654073
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2020

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: 02/08/2018
• Device Model Number: D001
• Device Catalogue Number: D001
• Device Lot Number: 103673
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1