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

Model Number	D001
Medical Device Problem Codes	High impedance (1291); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As no further information regarding this event is expected, our investigation is complete.This report will be updated should additional information be provided.
Event or Problem Description
It was reported that this patient's implanted system had delivered a shock which resulted in code 1005 being exhibited which is indicative of a shock into an open lead.A high out of range shock impedance measurement of greater than 125 ohms was also observed.The system has been reprogrammed and remains in service.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: 9638262
• Report Number: 2124215-2020-01626
• Device Sequence Number: 16841934
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/28/2020

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: 01/08/2018
• Device Model Number: D001
• Device Catalogue Number: D001
• Device Lot Number: 103361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 01/28/2020
• Patient Sequence Number: 1