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

Model Number D001

Device Problems High impedance (1291); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2019

Event Type  malfunction  

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 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
• Type of Device: 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: 9638262
• MDR Text Key: 176638588
• Report Number: 2124215-2020-01626
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526533723
• UDI-Public: 00802526533723
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P960040/S306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 01/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1