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

Model Number 101-9812

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

Patient Problems Bruise/Contusion (1754); Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 05/01/2022

Event Type  Injury  

Event Description

It was reported that patient stated he was able to walk further after the initial implant of the indirect decompression spacer, and the device worked for the pain in his legs, however, not for the additional pain in his lower back.As such, the patient was administered pain medication.The patient also noted having experienced bruising on his back near the device.The bruising was not seen by the physician and the cause was unknown.The patient felt as though the device was not working and requested to have the spacer explanted.During the explant procedure, the physician had difficulty dissecting down to the device as there was scar tissue or bone growth over the device, blocking the inserter.The patient began to have excess bleeding and increased co2 and the procedure was aborted with the device left in-situ.The patient has recovered postoperatively without incident.The lot number of the device is unknown despite good faith efforts to obtain.

• 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 Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 14753591
• MDR Text Key: 294396495
• Report Number: 3006630150-2022-02960
• Device Sequence Number: 1
• Product Code: NQO
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/21/2022

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: 101-9812
• Device Catalogue Number: 101-9812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2022
• Initial Date FDA Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention
• Patient Sex: Male