MAUDE Adverse Event Report: EBI, LLC SPINAL PAK CONTROLLER; STIMULATOR, SPINAL PAK, NON-INVASIVE

Catalog Number 1067716

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported that the patient is feeling discomfort while wearing the spinal pak unit.The patient stated that she was getting a sharp pain while using the device.The pain level is below the surface and the pain level is a ten out of ten.The patient had back surgery and is taking all kinds of medication.The patient spoke to the doctor and was told to only wear the unit for four hours a day.The patient was advised to conduct a time test.No further consequences have been reported at this time.

• Brand Name: SPINAL PAK CONTROLLER
• Type of Device: STIMULATOR, SPINAL PAK, NON-INVASIVE
• Manufacturer (Section D): EBI, LLC; 1 gatehall dr; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC; 1 gatehall dr; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 1 gatehall dr; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 17484312
• MDR Text Key: 320661829
• Report Number: 0002242816-2023-00084
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00812301020218
• UDI-Public: 00812301020218
• Combination Product (y/n): N
• Reporter Country Code: US
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 1067716
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic