MAUDE Adverse Event Report: EBI, LLC. SPINALPAK 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)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

The device was not returned to zimvie for investigation.The reported event was unable to be confirmed due to limited information received from the customer.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.Zimvie complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2022.

Event Description

It was reported that the patient is having stronger than normal headaches after treating with the spinal pak device.The patient was advised to not use the device for the moment, to consult with his doctor, and wait for further guidance.The patient stated that he has very bad headaches.The patient reported that he had an l5-s1 fusion.The patient stated that the headaches started the same day he started treatment with the stimulator.The patient reported that he has polyneuropathy (dead nerves) on the spine.The patient stated did not call his doctor.The patient stated that he had headaches last week but not as severe as they are now.The patient is using etodolac 600 mg.Which he had at home for the neuropathy.The patient stated that the pain is below the skin.The patient rated the pain as an 8 to 10, which is considered severe.The patient has a headache right now which is 4 or 5.The patient has not increased his daily activity.The patient is not having physical therapy.The patient has laser therapy on the spine.

Event Description

It was reported that the patient is having stronger than normal headaches after treating with the spinal pak device.The patient was advised to not use the device for the moment, to consult with his doctor, and wait for further guidance.The patient stated that he has very bad headaches.The patient reported that he had an l5-s1 fusion.The patient stated that the headaches started the same day he started treatment with the stimulator.The patient reported that he has polyneuropathy (dead nerves) on the spine.The patient stated did not call his doctor.The patient stated that he had headaches last week but not as severe as they are now.The patient is using etodolac 600 mg.Which he had at home for the neuropathy.The patient stated that the pain is below the skin.The patient rated the pain as an 8 to 10, which is considered severe.The patient has a headache right now which is 4 or 5.The patient has not increased his daily activity.The patient is not having physical therapy.The patient has laser therapy on the spine.

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 pain.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: impact code added 4648-insufficient information.H6: device code updated to 2682 - patient-device incompatibility.H6: investigation code added to 3331 - analysis of production records.H6: clinical code added 1994 - pain.H6: investigation code added to 3331 - analysis of production records.H6: investigation code added to 4114 - device not returned.H6: investigation code added to 4119 ¿ insufficient information available.H6: investigation findings code added to 3221: no findings available.H6: investigation conclusion added to 4315- cause not established.H10: additional narratives/data.The following sections have been corrected: h6: device code updated to 2993: adverse event without identified device or use problem.

• Brand Name: SPINALPAK 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: 15506687
• MDR Text Key: 300871432
• Report Number: 0002242816-2022-00111
• 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: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• 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: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2022
• 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