MAUDE Adverse Event Report: EBI, LLC. SPINALPAK ASSEMBLY

Model Number N/A

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

Patient Problem No Code Available (3191)

Event Date 05/26/2016

Event Type  Injury  

Manufacturer Narrative

Review of the device history records show that the lot was released with no recorded anomaly or deviation.(b)(6), ph.D is the manager of r&d for biologics and electrical stimulation.She provided a clinical review of the complaint.Ms.(b)(6) states: "first, i want to mention that i expect it was a c5 ¿c7 anterior cervical fusion (acf) procedure that was performed.This is an off label use of our product.Fibromyalgia is a disorder characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood issues.She may have fibromyalgia, but i¿m not sure that i would expect that to cause her to have a hard time breathing.That said, patients with fibromyalgia often have anxiety, and it is possible that by starting treatment with the stimulator she induced anxiety/or a potential panic attack that could cause a person to have a hard time breathing.I¿d like to mention that i know there have been patients enrolled in our clinical studies with fibromyalgia that have not had any complications reported, so i don¿t think that the stimulator would have triggered something specific to her having fibromyalgia.Shortness of breath, and having a hard time breathing can also be symptoms of a heart attack.If the patient does have a pace maker, defibrillator, etc.That is something that the device may affect.We¿ve not studied it¿s use with different cardiovascular products, and we recommend patients try the device under the supervision of a cardiologist.That said, the symptoms she described could be attributed to anxiety, cardiovascular disease, or other [conditions] that may not be associated with our device." 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

The patient indicated that she had a hard time breathing shortly after the stimulator was applied.The patient kept the device on until she went to the er where she was instructed to remove and stop wearing it.

Manufacturer Narrative

A third and final attempt for additional information was made on august 18, 2016, however, no additional information has been received and the device was not returned for evaluation.Off-label, unapproved, or contraindicated use was added.

• 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: 5750735
• MDR Text Key: 48209617
• Report Number: 0002242816-2016-00017
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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)L24200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2016
• Initial Date FDA Received: 06/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2016
• 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: 61 YR