MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORIGEN CRT-D; IMPLANTABLE CHF GENERATOR

Model Number	G051
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited multiple high out of range pacing impedance measurements of greater than 2000 ohms on the right ventricular (rv) channel.The rv lead is a non-boston scientific product.No changes were made to the system and the crt-d remains in service.No adverse patient effects were reported.

• Brand Name: ORIGEN CRT-D
• Common Device Name: IMPLANTABLE CHF GENERATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8006202
• Report Number: 2124215-2018-60455
• Device Sequence Number: 11109358
• Product Code: NIK
• UDI-Device Identifier: 00802526534478
• UDI-Public: 802526534478
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/25/2018

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: 03/02/2017
• Device Model Number: G051
• Device Catalogue Number: G051
• Device Lot Number: 108647
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 10/25/2018
• Patient Sequence Number: 1
• Patient Age: 62 YR