MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORIGEN X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)

Model Number	G058
Medical Device Problem Codes	Signal Artifact/Noise (1036); High impedance (1291); High Capture Threshold (3266); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system exhibited high out of range pacing impedance in the right ventricular (rv) and left ventricular (lv) leads.The device was also noted to exhibit beeping tones.The leads were measured with the pacing system analyzer (psa) and the lv lead measurements were noted to be in range.The rv lead measurements continued to be high and high threshold was also noted.It was mentioned that the rv lead could exhibit a lead conductor fracture or an insulation damage, and noise was also observed in this lead.Subsequently, the crt-d and rv lead were replaced and the new measurements after the products replacement were within adequate range.The lv lead remains in service.No additional adverse patient effects.The crt-d device is expected to be returned for analysis.Additional information indicates the crt-d device was replaced to be on the safe side due to the high out of range impedance measurements and the beeping tones observed were also caused by the high impedance measurements.In addition, the lv lead high out of range impedance is believed to be due to the stimulation being set against the rv lead.
Additional Manufacturer Narrative
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.<
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system exhibited high out of range pacing impedance in the right ventricular (rv) and left ventricular (lv) leads.The device was also noted to exhibit beeping tones.The leads were measured with the pacing system analyzer (psa) and the lv lead measurements were noted to be in range.The rv lead measurements continued to be high and high threshold was also noted.It was mentioned that the rv lead could exhibit a lead conductor fracture or an insulation damage, and noise was also observed in this lead.Subsequently, the crt-d and rv lead were replaced and the new measurements after the products replacement were within adequate range.The lv lead remains in service.No additional adverse patient effects.The crt-d device is expected to be returned for analysis.Additional information indicates the crt-d device was replaced to be on the safe side due to the high out of range impedance measurements and the beeping tones observed were also caused by the high impedance measurements.In addition, the lv lead high out of range impedance is believed to be due to the stimulation being set against the rv lead.The device was returned for analysis.

• Brand Name: ORIGEN X4 CRT-D
• Common Device Name: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 14640120
• Report Number: 2124215-2022-20291
• Device Sequence Number: 5771312
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2022

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: 05/19/2019
• Device Model Number: G058
• Device Catalogue Number: G058
• Device Lot Number: 171667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Unknown