INFINION? PRO
Report
- Report Number
- 3006630150-2025-09483
- Event Type
- Injury
- Date Received
- October 27, 2025
- Date of Event
- September 26, 2025
- Report Date
- December 24, 2025
- Manufacturer
- BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
- Product Code
- LGW
- UDI-DI
- 00191506018733
- PMA / PMN Number
- P030017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCK D2B: LGW, QRB. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: UPN: M365SC2318700; MODEL: SC-2318-70; SERIAL: (B)(6); BATCH: 5005589; UDI: (B)(4). BRAND NAME: WAVEWRITER ALPHA? UPN: M365SC12320; MODEL: SC-1232; SERIAL: (B)(6); BATCH: 791536; UDI: (B)(4).
BLOCK D2B: LGW, QRB. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: UPN: M365SC2318700. MODEL: SC-2318-70. SERIAL: (B)(6). BATCH: 5005589. UDI: (B)(4).
ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: NULL UPN: UNK-P-SCS-LINEAR_LEADS MODEL: NULL SERIAL: NULL BATCH: NULL. BRAND NAME: NULL UPN: UNK-P-SCS-LINEAR_LEADS MODEL: NULL SERIAL: NULL BATCH: NULL.
IT WAS REPORTED THAT FOLLOWING A SPINAL CORD STIMULATION (SCS) IMPLANT PROCEDURE THE PATIENT EXPERIENCED CLAUDICATION AND COULD NOT MOVE THEIR LEFT LOWER LIMB. THE PATIENT WAS ADMITTED TO THE HOSPITAL WARD FOR MONITORING. THE FOLLOWING DAY THE PATIENT STILL COULD NOT MOVE THE LIMB. A MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED WHICH REVEALED A HERNIATED DISC AT THORACIC SPINE LEVEL. IT WAS ASSESSED THAT THE SCS LEADS IMPLANTED MADE THE MEDULAR COMPRESSION WORSE, WHICH EXPLAINED THE CLAUDICATION. THE DAY AFTER THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE ENTIRE SCS SYSTEM WAS EXPLANTED. IN ADDITION, THE PATIENT UNDERWENT A THORACIC DISCECTOMY. THE EVENT WAS ASSESSED AS SERIOUS, WITH A CAUSAL RELATIONSHIP TO THE DEVICE, PROCEDURE, AND STIMULATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PATIENT IS RECOVERING. ADDITIONAL INFORMATION WAS RECEIVED THAT THE THORACIC DISCECTOMY TOOK PLACE ON (B)(6) 2025. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. THE PATIENT HAS NOT REGAINED FEELING. ADDITIONAL INFORMATION WAS RECEIVED THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND IS RECOVERING.
IT WAS REPORTED THAT FOLLOWING A SPINAL CORD STIMULATION (SCS) IMPLANT PROCEDURE THE PATIENT EXPERIENCED CLAUDICATION AND COULD NOT MOVE THEIR LEFT LOWER LIMB. THE PATIENT WAS ADMITTED TO THE HOSPITAL WARD FOR MONITORING. THE FOLLOWING DAY THE PATIENT STILL COULD NOT MOVE THE LIMB. A MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED WHICH REVEALED A HERNIATED DISC AT THORACIC SPINE LEVEL. IT WAS ASSESSED THAT THE SCS LEADS IMPLANTED MADE THE MEDULAR COMPRESSION WORSE, WHICH EXPLAINED THE CLAUDICATION. THE DAY AFTER THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE ENTIRE SCS SYSTEM WAS EXPLANTED. IN ADDITION, THE PATIENT UNDERWENT A THORACIC DISCECTOMY. THE EVENT WAS ASSESSED AS SERIOUS, WITH A CAUSAL RELATIONSHIP TO THE DEVICE, PROCEDURE, AND STIMULATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE PATIENT IS RECOVERING. ADDITIONAL INFORMATION WAS RECEIVED THAT THE THORACIC DISCECTOMY TOOK PLACE ON 01-OCT-2025. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. THE PATIENT HAS NOT REGAINED FEELING.
IT WAS REPORTED THAT FOLLOWING A SPINAL CORD STIMULATION (SCS) IMPLANT PROCEDURE THE PATIENT EXPERIENCED CLAUDICATION AND COULD NOT MOVE THEIR LEFT LOWER LIMB. THE PATIENT WAS ADMITTED TO THE HOSPITAL WARD FOR MONITORING. THE FOLLOWING DAY THE PATIENT STILL COULD NOT MOVE THE LIMB. A MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED WHICH REVEALED A HERNIATED DISC AT THORACIC SPINE LEVEL. IT WAS ASSESSED THAT THE SCS LEADS IMPLANTED MADE THE MEDULAR COMPRESSION WORSE, WHICH EXPLAINED THE CLAUDICATION. THE DAY AFTER THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE ENTIRE SCS SYSTEM WAS EXPLANTED. IN ADDITION, THE PATIENT UNDERWENT A THORACIC DISCECTOMY. THE EVENT WAS ASSESSED AS SERIOUS, WITH A CAUSAL RELATIONSHIP TO THE DEVICE, PROCEDURE, AND STIMULATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2794139 | INFINION? PRO | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | BOSTON SCIENTIFIC NEUROMODULATION CORPORATION | SC-2318-70 | 5005598 | 00191506018733 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Female | Required Intervention| H |