MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION INFINION? PRO; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-2318-70
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Arrest (1762)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d2b: pro code (product code): qrb.Additional suspect medical device component involved in the event: product family: scs-linear leads, upn: m365sc2318700, model: sc-2318-70, serial: (b)(6), batch: (b)(6), udi: (b)(4).
Event or Problem Description
It was reported that during implant procedure, while the patient was under sedation, the physician was placing the right lead when the patients heart rate began to decrease.Medications were administered, but the heart rate continued to decline, resulting in cardiac arrest.The implanting physician removed the leads, and emergency resuscitation efforts commenced.The patient was intubated in the operating room.Emergency medical services were contacted, and the patient was transported to the hospital for intensive care.The caused of cardiac arrest was unknown.No device malfunction suspected.The explanted device components will not be return as it was discarded.
Event or Problem Description
It was reported that during implant procedure, while the patient was under sedation, the physician was placing the right lead when the patient's heart rate began to decrease.Medications were administered by the anesthesia team, but the heart rate continued to decline, resulting in cardiac arrest.The implanting physician removed the leads, and emergency resuscitation efforts commenced.The patient was intubated in the operating room.Emergency medical services were contacted, and the patient was transported to the hospital.The explanted device components will not be return as it was disposed.Additional information was received that the patient passed away.
Additional Manufacturer Narrative
Block d2b: pro code (product code): qrb.Additional suspect medical device component involved in the event: product family: scs-linear leads, upn: m365sc2318700, model: sc-2318-70, serial: (b)(6), batch: 5003819, udi: (b)(4).
Additional Manufacturer Narrative
Block d2b: pro code (product code): lgw, qrb.Additional suspect medical device component involved in the event: product family: scs-linear leads.Upn: m365sc2318700.Model: sc-2318-70.Serial: (b)(6).Batch: 5003819.Udi: (b)(4).
Event or Problem Description
It was reported that during implant procedure, while the patient was under sedation, the physician was placing the right lead when the patients heart rate began to decrease.Medications were administered by the anesthesia team, but the heart rate continued to decline, resulting in cardiac arrest.The implanting physician removed the leads, and emergency resuscitation efforts commenced.The patient was intubated in the operating room.Emergency medical services were contacted, and the patient was transported to the hospital.The explanted device components will not be returned as they were discarded by the medical facility.Additional information was received that the patient passed away.Additional information was received that the physician does not know the cause of death.The patient did not have any comorbidities which were believed to have contributed to the patients death.It was noted that after the patient was placed on a ventilator, the patients code status was eventually changed to do not resuscitate (dnr) at the family request.
Event or Problem Description
It was reported that during implant procedure, while the patient was under sedation, the physician was placing the right lead when the patients heart rate began to decrease.Medications were administered by the anesthesia team, but the heart rate continued to decline, resulting in cardiac arrest.The implanting physician removed the leads, and emergency resuscitation efforts commenced.The patient was intubated in the operating room.Emergency medical services were contacted, and the patient was transported to the hospital.The explanted device components will not be returned as they were discarded by the medical facility.Additional information was received that the patient passed away.Additional information was received that the physician does not know the cause of death.The patient did not have any comorbidities which were believed to have contributed to the patients death.It was noted that after the patient was placed on a ventilator, the patients code status was eventually changed to do not resuscitate (dnr) at the family request.
Additional Manufacturer Narrative
Block d2b: pro code (product code): lgw, qrb.Additional suspect medical device component involved in the event: product family: scs-linear leads.Upn: m365sc2318700.Model: sc-2318-70.Serial: (b)(6).Batch: 5003819.Udi: (b)(4).

• Brand Name: INFINION? PRO
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 23739429
• Report Number: 3006630150-2025-11245
• Device Sequence Number: 21420162
• Product Code: LGW
• UDI-Device Identifier: 00191506018733
• UDI-Public: (01)00191506018733(17)270902(10)5006533
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/24/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: SC-2318-70
• Device Catalogue Number: SC-2318-70
• Device Lot Number: 5006533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 11/24/2025; 12/18/2025; 02/10/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 12/17/2025; 01/08/2026; 02/24/2026
• Date Device Manufactured: 09/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male