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

Model Number N/A

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

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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 received the spinalpak on (b)(6) 2016.It is reported that a few days after receiving the device, the patient was unable to speak and began complaining of pain in his eyes, middle of his head, down his back, and the middle of his spine.The patient's doctor advised the patient to go to the emergency room.At the emergency room, it is reported a ct scan was performed and yielded negative results "for everything." it is reported that in the hospital bed, the patient would "rise in pain over and over - it looked like a seizure." it is reported that the people in the emergency room stated that it could be nerve stimulation.It is reported that the patient went to the va and within twenty four hours the patient had no more pain and he was able to speak again.It is reported that once the stimulator was removed from the patient, he felt better.

• Brand Name: SPINALPAK ASSEMBLY
• Type of Device: BONE 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: 6076593
• MDR Text Key: 59070084
• Report Number: 0002242816-2016-00034
• 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,other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 10/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• 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)L26795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 78 YR