MAUDE Adverse Event Report: EBI, LLC. SPINALPAK ASSEMBLY; STIMULATOR, SPINAL PAK, NON-INVASIVE (SOFT TOUCH ELECTRODES, 72R)

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Discomfort (2330); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

Zimvie complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2022.Concomitant medical products: medical product: unknown.Concomitant medical products: therapy date: unknown.Customer has indicated that the product is in process of being returned to zimvie for investigation.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient described her first day of treatment caused numbness in her arms and hands and a swollen / constricted feeling in her throat.The patient claims her pain was a 1.5 out of 10, but it definitely scared her.The first treatment with the stimulator was also the first day of physical therapy.She has since had additional physical therapy with no subsequent pain or numbness.The patient also advised that she went back to work recently and stopped using her neck brace.The surgeon advised that if the treatment made the patient uncomfortable, to discontinue, as it was up to her.The patient did not experience any skin irritation.In general, she does have very sensitive skin.In the past, she would break out in hives if she walked in the grass or stayed in the sun too long, or if the temperature outside changes too quickly.No notable allergies have been found.When she experienced a constriction of her throat, she claims it took place between 24 and 48 hours to feel better.The patient currently taking gabapentin orally since her surgery in may with no adverse reactions.She has not had a constriction of the throat in the past.The patient advises she intends to try treatment again over the weekend for one hour to test how she feels.She will report back to us afterward.The patient stated on (b)(6) 2022, that she is up to treating for 2 hours a day and still having issues with her throat constricting.The patient stated that the sales representative will speak to her doctor.The patient also had a scheduled office visit with the doctor tomorrow.It was later reported on (b)(6) 2022, that the patient's doctor told her to stop using the unit because of the discomfort she had experienced.The patient reported that nothing was prescribed by the doctor and she did not take any over-the-counter medication for the discomfort.The patient will stop using the product and will return the unit to us.The patient reported that she was using the electrodes on the back of her neck, per instructions from the sales representative.No further information has been reported.

• Brand Name: SPINALPAK ASSEMBLY
• Type of Device: STIMULATOR, SPINAL PAK, NON-INVASIVE (SOFT TOUCH ELECTRODES, 72R)
• 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: 15246041
• MDR Text Key: 298113813
• Report Number: 0002242816-2022-00090
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00812301020218
• UDI-Public: 00812301020218
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/10/2022
• 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): Required Intervention
• Patient Sex: Female