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

Catalog Number 1067716

Device Problem Patient-Device Incompatibility (2682)

Patient Problems High Blood Pressure/ Hypertension (1908); Pain (1994)

Event Type  Injury  

Event Description

It was reported that the patient experienced elevated blood pressure while using the spinal pak device.The patient spoke with her doctor and would like to discontinue treatments and return the device.The patient has fibromyalgia and her pain got much worse when treated with the spinal pak device.The patient had a pain level of 3 after the surgery and when she treated with the spinal pak device her pain level went to a 6.After a couple of days, the patient was admitted to the hospital with a pain level of 8 or 9.The patient stated that when she discontinued treatment, her pain subsided immediately.The patient consulted with her doctor, and he agreed that she should discontinue treatment.No additional information has been reported at this time.

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The device history records are unable to be reviewed.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 followup report will be sent.

• Brand Name: SPINAL PAK ASSEMBLY
• Type of Device: SPINAL PAK NON-INVASIVE STIMULATOR
• Manufacturer (Section D): EBI, LLC; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 18077221
• MDR Text Key: 327480041
• Report Number: 0002242816-2023-00118
• 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: 11/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• 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
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic