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

Model Number	G058
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety core and that both brady and tachy therapy remained available.Review of device memory identified an error.The error resulted in software resets performed in an attempt to correct an identified memory inconsistency.The corrupted memory was corrected in the laboratory and the device reverted to normal operation.The cause of the memory inconsistency was not able to be determined through laboratory testing but was likely the result of exposure to radiation, either therapeutic or environmental.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was found to be in safety core.Surgical intervention was performed and the crt-d was explanted and replaced.No additional adverse patient effects were reported.

• 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: 9649685
• Report Number: 2124215-2020-02091
• Device Sequence Number: 2783929
• 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: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/30/2020

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: 08/10/2018
• Device Model Number: G058
• Device Catalogue Number: G058
• Device Lot Number: 155079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 01/30/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention