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

Model Number	D003
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an inquiry regarding high out of range pace impedance measurements was requested when it comes to this device.A review of the remote monitoring data by technical services (ts) noted that the first high right ventricular lead measurements started (b)(6) 2018.It was noted that the values were greater then 3,000 ohms.At this time the system remains implanted.No adverse patient effects were reported.
Event or Problem Description
It was reported that an inquiry regarding high out of range pace impedance measurements was requested when it comes to this device.A review of the remote monitoring data by technical services (ts) noted that the first high right ventricular lead measurements started december 2018.It was noted that the values were greater then 3,000 ohms most of last year.Ts noted that due to that fact that we longer can evaluate the leads performance a lead evaluation should be considered.Additional information noted that a revision took place and the competitor lead was explanted, while the device remained implanted.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that an inquiry regarding high out of range pace impedance measurements was requested when it comes to this device.A review of the remote monitoring data by technical services (ts) noted that the first high right ventricular lead measurements started (b)(6) 2018.It was noted that the values were greater then 3,000 ohms most of last year.Ts noted that due to that fact that we longer can evaluate the leads performance a lead evaluation should be considered.At this time the remains implanted.No adverse patient effects were reported.

• 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
• MDR Report Key: 10255412
• Report Number: 2124215-2020-13457
• Device Sequence Number: 19439595
• Product Code: LWS
• UDI-Device Identifier: 00802526533761
• UDI-Public: 00802526533761
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2020

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: 02/27/2020
• Device Model Number: D003
• Device Catalogue Number: D003
• Device Lot Number: 250956
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 06/22/2020; 08/03/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 07/17/2020; 09/30/2020
• Patient Sequence Number: 1
• Patient Age: 73 YR