MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION SUPERION INDIRECT DECOMPRESSION SYSTEM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Model Number 101-9814

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Weakness (1967); Swelling/ Edema (4577)

Event Date 03/30/2021

Event Type  Injury  

Event Description

It was reported that the patient experienced a non-serious adverse event of right lower extremity weakness with moderate severity.This event occurred on the same day as the implant procedure.The patient had an magnetic resonance imaging and acupuncture treatments.The event has resolved.The event was deemed as possibly related to the device and procedure based on the timing of the event.

Event Description

It was reported that the patient experienced a non-serious adverse event of right lower extremity weakness with moderate severity.This event occurred on the same day as the implant procedure.The patient had an magnetic resonance imaging and acupuncture treatments.The event has resolved.The event was deemed as possibly related to the device and procedure based on the timing of the event.Additional information was received that there will be no further action at this time.The right lower extremity weakness was due to unknown etiology.

Event Description

It was reported that the patient experienced a non-serious adverse event of right lower extremity weakness with moderate severity.This event occurred on the same day as the implant procedure.The patient had an magnetic resonance imaging and acupuncture treatments.The event has resolved.The event was deemed as possibly related to the device and procedure based on the timing of the event.Additional information was received that there will be no further action at this time.The right lower extremity weakness was due to unknown etiology.Additional information was received that the magnetic resonance imaging results showed mild postsurgical soft tissue edema in the lumbar 4 - lumbar 5 levels with moderate to severe arthropathy.Acupuncture treatments were completed.

Event Description

It was reported that the patient experienced a non-serious adverse event of right lower extremity weakness with moderate severity.This event occurred on the same day as the implant procedure.The patient had an magnetic resonance imaging and acupuncture treatments.The event has resolved.The event was deemed as possibly related to the device and procedure based on the timing of the event.Additional information was received that there will be no further action at this time.The right lower extremity weakness was due to unknown etiology.Additional information was received that the magnetic resonance imaging results showed mild postsurgical soft tissue edema in the lumbar 4 - lumbar 5 levels with moderate to severe arthropathy.Acupuncture treatments were completed.Additional information was received that the event is not device or procedure related.

• Brand Name: SUPERION INDIRECT DECOMPRESSION SYSTEM
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): VERTIFLEX INC; 2714 loker ave. west; carlsbad CA 92010
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 12833378
• MDR Text Key: 280928489
• Report Number: 3006630150-2021-06524
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000550
• UDI-Public: 00884662000550
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 101-9814
• Device Catalogue Number: 101-9814
• Device Lot Number: 800176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female