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 Problem Pain (1994)

Event Date 03/23/2024

Event Type  Injury  

Event Description

It was reported that the superion indirect decompression spacer clinical study patient, a4082 scope study, experienced moderate pain in both lower extremities.The patient was sent to the emergency room (er) to rule out deep vein thrombosis (dvt).The er physician ordered an ultrasound which came back normal.The patient was advised to follow-up with their primary care physician and vascular doctor.

Event Description

It was reported that the superion indirect decompression spacer clinical study patient, (b)(6) scope study, experienced moderate pain in both lower extremities.The patient was sent to the emergency room (er) to rule out deep vein thrombosis (dvt).The er physician ordered an ultrasound which came back normal.The patient was advised to follow-up with their primary care physician and vascular doctor.Additional information was received that the patient symptoms included muscle weakness, numbness and tingling.No treatment was provided to the patient while in the er.

• 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): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 19130871
• MDR Text Key: 340446840
• Report Number: 3006630150-2024-02419
• 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
• Report Date: 05/20/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: 101-9814
• Device Catalogue Number: 101-9814
• Device Lot Number: 29539391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• 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): Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female