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

Model Number 101-9812

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Pain (1994); Discomfort (2330); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2023

Event Type  Injury  

Event Description

It was reported that the superion indirect decompression system implant patient experienced an unknown adverse event.Despite multiple good faith efforts, boston scientific has been unable to obtain additional information regarding the adverse event, any medical or surgical intervention, product information, and patient outcome.

Event Description

It was reported that the superion indirect decompression system implant patient experienced an unknown adverse event.Despite multiple good faith efforts, boston scientific has been unable to obtain additional information regarding the adverse event, any medical or surgical intervention, product information, and patient outcome.Additional information was received indicating that the indirect decompression system implant patient experienced neurological sequelae a day after the implant procedure and also experienced more severe discomfort and pain than prior to being implanted.The patient underwent a revision procedure the next day to remove the implant.The physician was unable to remove the device as it had migrated into the epidural space and would require a laminectomy to remove.The procedure was aborted, and the device remains implanted.Additional information was received that indicates the patient underwent an explant procedure where the indirect decompression system implant was explanted the following day.

Event Description

It was reported that the superion indirect decompression system implant patient experienced an unknown adverse event.Despite multiple good faith efforts, boston scientific has been unable to obtain additional information regarding the adverse event, any medical or surgical intervention, product information, and patient outcome.Additional information was received indicating that the indirect decompression system implant patient experienced neurological sequelae a day after the implant procedure and also experienced more severe discomfort and pain than prior to being implanted.The patient underwent a revision procedure the next day to remove the implant.The physician was unable to remove the device as it had migrated into the epidural space and would require a laminectomy to remove.The procedure was aborted, and the device remains implanted.

• 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: 18580570
• MDR Text Key: 333736608
• Report Number: 3006630150-2024-00249
• Device Sequence Number: 1
• Product Code: NQO
• UDI-Device Identifier: 00884662000543
• UDI-Public: 00884662000543
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101-9812
• Device Catalogue Number: 101-9812
• Device Lot Number: 29244067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2022
• 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): Required Intervention
• Patient Sex: Male