MAUDE Adverse Event Report: EBI, LLC. SPINALPAK ASSEMBLY

Model Number N/A

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

Patient Problems Pain (1994); Numbness (2415); Shock from Patient Lead(s) (3162)

Event Type  Injury  

Manufacturer Narrative

Review of the device history records show that the device was released with no recorded anomaly or deviation.The patient does not wish to return the product for an evaluation.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 is reported that the patient experienced shocking sensations while using the spinalpak.Additionally, the patient advised she could not feel the right side of her foot and her left thigh.The patient advised she now has to go for therapy for pain management.The patient added that she went to see her physician for her symptoms and he prescribed her gabapentin for her nerves.She advised that her physician told her to stop using the spinalpak immediately.

Manufacturer Narrative

A clinical assessment was provided by (b)(4).She states: "the chance of electrical shock was one of the adverse events that we say has a remote (<1%) chance of occurring [in the instructions for use].It is possible that she may have experienced something, as it is a risk that we say is possible.That said, what she describes seems over and above what the expected adverse event would be.What she describes would not be something i would expect to be attributable to our device.Her symptoms (can¿t feel foot or thigh) and general pain (since she mentions pain management) are things that could occur due to many different things and would be hard to say for sure that it was due to the device.".

• Brand Name: SPINALPAK ASSEMBLY
• Type of Device: SPINALPAK
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: michelle cole ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 5704549
• MDR Text Key: 46760321
• Report Number: 0002242816-2016-00015
• Device Sequence Number: 1
• Product Code: LOF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP850022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 1067716
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention