MAUDE Adverse Event Report: EBI, LLC. SPINALPAK STIMULATOR, BIOMET; SPINAL PAK NON-INVASIVE STIMULATOR

Model Number N/A

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock (2072)

Event Type  Injury  

Manufacturer Narrative

Zimvie complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2022.Concomitant medical products: unknown.Therapy date: unknown.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient had 3 shocks while wearing the spinal pak device.The patient stated that he was a little sweaty and he took the unit off immediately.The patient stated that his back was sweaty and his shirt was damp.The patient will not wear the device when he is sweating.He believed the brace is putting too much pressure on the electrodes and the patient then disconnected the call.The patient stated that the device did not cause any pain.The patient experienced more so discomfort.The patient also stated that he did not seek medical treatment for the issue.The patient stated that he is using the unit without the back brace and is no longer having any issues.No further consequences have been reported.

• Brand Name: SPINALPAK STIMULATOR, BIOMET
• Type of Device: SPINAL PAK NON-INVASIVE STIMULATOR
• 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: 15851307
• MDR Text Key: 304176161
• Report Number: 0002242816-2022-00138
• 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: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• 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: 1067717
• Device Lot Number: N/A
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2022
• 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: Male