INFINION? PRO
Report
- Report Number
- 3006630150-2025-11245
- Event Type
- Injury
- Date Received
- December 8, 2025
- Date of Event
- November 12, 2025
- Report Date
- February 24, 2026
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 00191506018733
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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).
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).
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).
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).
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.
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.
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.
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 139996 | INFINION? PRO | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2318-70 | 5006533 | 00191506018733 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Male | Death| R |