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

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It was reported by the patient who stated, that she is experiencing pain while using the spinal pak stimulator.The patient states the pain is in her lower back.The patient is treating the l3-l5.The pain is located in back of her head.The patient rated the pain as a 10 on a scale of 1 to 10, with 10 being the highest.The patient has not increased her daily activities.She has stop wearing unit and feels much better.The patient did not seek medical treatment.The patient is taking tylenol for pain.The patient will be contacting her doctor, will call back with update.It was reported that no further information is available.

Manufacturer Narrative

(b)(4).Date of event: the event occurred sometime in (b)(6) 2021.Concomitant medical products: medical product: 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The device not was returned to zimvie for investigation.The reported event was not verifiable after the investigation associated with skin irritation.The device history record was reviewed and no discrepancies related to the reported event were found.No physical and/or functional condition could be found after the dhr that could be considered a causal factor for the reported complaint.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly zimvie will continue to monitor for trends.H6: device code updated to 2993: adverse event without identified device or use problem.

Event Description

It was reported by the patient who stated, that she is experiencing pain while using the spinal pak stimulator.The patient states the pain is in her lower back.The patient is treating the l3-l5.The pain is located in back of her head.The patient rated the pain as a 10 on a scale of 1 to 10, with 10 being the highest.The patient has not increased her daily activities.She has stop wearing unit and feels much better.The patient did not seek medical treatment.The patient is taking tylenol for pain.The patient will be contacting her doctor, will call back with update.It was reported that no further information is available.

• Brand Name: SPINAL PAK ASSEMBLY
• 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: 12672527
• MDR Text Key: 281273478
• Report Number: 0002242816-2021-00184
• 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,Followup
• Report Date: 10/20/2022

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 10/21/2021
• Supplement Dates Manufacturer Received: 09/22/2022
• Supplement Dates FDA Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2021
• 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