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

Catalog Number 1067716

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Discomfort (2330)

Event Type  Injury  

Event Description

It was reported that the patient was experiencing discomfort while using the spinal pak device.The patient described she was experiencing severe pain while wearing the device.The pain is up and down her right leg.The pain started on the second day of using the device.The patient rated the pain as a 10 on a scale of 1 to 10, with 10 being the highest.The patient claims she has not increased her daily activities.The patient has called her doctor and left a message for a return call.The patient advised she was using an ointment cream on her leg.The customer service representative advised to conduct a time test and back if there are any issues during the time test.No additional patient consequences have been reported.

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 follow up report will be sent.

• Brand Name: SPINAL PAK ASSEMBLY
• 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: 17599116
• MDR Text Key: 321689598
• Report Number: 0002242816-2023-00090
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00812301020225
• UDI-Public: 00812301020225
• 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: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• 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