MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORIGEN X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number	G058
Medical Device Problem Codes	High impedance (1291); Failure to Sense (1559); Connection Problem (2900)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The returned device was analyzed.A visual inspection of the device header and case noted no anomalies.The seal plugs were intact and all set screws moved freely.Pin gauge testing, designed to verify proper port dimensions, was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.The associated investigation noted evidence indicating difficulty may have been encountered fully inserting a df-4 lead into the header of this device resulting in the out-of-range pacing impedance measurements that were observed clinically.
Event or Problem Description
It was reported that during a device change out procedure, the chronic non-boston scientific right ventricular (rv) lead was connected to this cardiac resynchronization therapy defibrillator (crt-d) but no sensing was observed and the pacing impedance measurements were high, out-of-range at greater than 3,000 ohms.The connections were checked, and the lead was tested again on the psa, with normal impedances noted.The lead was reconnected to the device but the issue did not resolve.A new device of the same model was tried and the same observations occurred.Therefore, the chronic rv lead was surgically abandoned and replaced with a boston scientific rv lead.This lead was connected to the second device and normal lead measurements were obtained.No adverse patient effects were reported.The first device was returned and is undergoing laboratory analysis.

• Brand Name: ORIGEN X4 CRT-D
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 10023740
• Report Number: 2124215-2020-10033
• Device Sequence Number: 11526309
• Product Code: NIK
• UDI-Device Identifier: 00802526534515
• UDI-Public: 00802526534515
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P010012/S341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2020

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: Health Professional
• Device Expiration Date: 05/22/2021
• Device Model Number: G058
• Device Catalogue Number: G058
• Device Lot Number: 216474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 05/05/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention