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	05/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a high, out of range pacing impedance (>3000 ohms) measurement was noted from a competitor's right ventricular (rv) lead.Boston scientific technical services were contacted and recommended in-clinic maneuvers to assess the rv lead integrity.Provocative maneuvers were performed and no noise was seen and the pacing impedance was in range.The physician elected to continue with remote monitoring and remote follow ups.The system remains implanted and in service.The patient was stable with no adverse consequences.

• 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: 10226564
• Report Number: 2124215-2020-12065
• Device Sequence Number: 3233848
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2020

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: 03/21/2020
• Device Model Number: D001
• Device Catalogue Number: D001
• Device Lot Number: 108217
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 07/02/2020
• Patient Sequence Number: 1
• Patient Age: 79 YR