MAUDE Adverse Event Report: EBI, LLC. SPINALPAK ASSEMBLY; SPINE STIMULATOR

Model Number N/A

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

Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694); Lead(s), Burn(s) From (3161); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The patient manual has instructions on placement of the electrodes and changing the electrodes and states "the patient can use whichever electrodes best suit their skin type." in addition, the manual states "if your skin becomes abnormally red at the electrode sites, the electrodes should be moved to either immediately above or below the original sites.If the redness does not go away after 48 hours once the electrodes are removed, you should contact your doctor." 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.This is report three of three for the same event.Reports one and two are reported on mfr #0002242816-2016-00023 and 0002242816-2016-00024.

Event Description

The patient reported after approximately a month of using the bone stimulator her skin was burned.She stated she used two different types of electrodes so she is not sure which one caused the burn.She stated she called her physician who called in a prescription for silvadene cream.She states she changed the electrodes twice a day and moved them around.She stated she is using the silvadene cream and is healing and will try using a different electrode.The patient later called to inform that her physician stated she had first and second degree burns.The patient stated her moles had gotten larger as well.

Manufacturer Narrative

A review of the device history records show the lot released with no recorded anomaly or deviation.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: SPINALPAK ASSEMBLY
• Type of Device: SPINE STIMULATOR
• 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: 6146285
• MDR Text Key: 61491792
• Report Number: 0002242816-2016-00040
• 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
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 07/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• 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: (01)00888480587903(21)L21662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention