MAUDE Adverse Event Report: EBI, LLC. SPINALPAK ASSEMBLY; STIMULATOR, SPINAL PAK, NON-INVASIVE (ELECTRODES COVER PATCHES)

Model Number N/A

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

Patient Problems Blister (4537); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

It was reported by the patient that she experienced irritation to cover patches.The patient states she knows it is the covers as the irritation is in a ring around the electrodes.The patient claims she changes electrodes and covers and rotates every 2 days.The patient reported that she washed with soap and water.The patient claims her skin is red, itchy, and has blisters.The patient stated she has sensitive skin, an allergy to nickel, and eczema.The patient also has seasonal allergies, and asthma and takes blood pressure medication.The patient reported that she contacted her surgeon who advised to pause treatment, rotate location daily, use neosporin to heal, and then wear electrodes as often as she can tolerate.The patient will pause until healed then discontinue wearing cover patches.It was reported that no further information is available.

Manufacturer Narrative

Zimvie complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2022.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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The device 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.The following sections have been updated: b4: date of this report added d3 manufacturer g1-2 contact office g3 date received by manufacturer g4 type of report h6: device code updated to 2682 - patient-device incompatibility h6: investigation code added to 3331 - analysis of production records h6: investigation code added to 4119 ¿ insufficient information available h6: investigation findings code added to 3221: no findings available h10: additional narratives/data the following sections have been corrected: h6: device code updated to 2993: adverse event without identified device or use problem.

Event Description

T was reported by the patient that she experienced irritation to cover patches.The patient states she knows it is the covers as the irritation is in a ring around the electrodes.The patient claims she changes electrodes and covers and rotates every 2 days.The patient reported that she washed with soap and water.The patient claims her skin is red, itchy, and has blisters.The patient stated she has sensitive skin, an allergy to nickel, and eczema.The patient also has seasonal allergies, and asthma and takes blood pressure medication.The patient reported that she contacted her surgeon who advised to pause treatment, rotate location daily, use neosporin to heal, and then wear electrodes as often as she can tolerate.The patient will pause until healed then discontinue wearing cover patches.It was reported that no further information is available.

• Brand Name: SPINALPAK ASSEMBLY
• Type of Device: STIMULATOR, SPINAL PAK, NON-INVASIVE (ELECTRODES COVER PATCHES)
• 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: 14637595
• MDR Text Key: 294841110
• Report Number: 0002242816-2022-00052
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00812301020195
• UDI-Public: 00812301020195
• 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: 10/18/2022

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: 122119
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/09/2022
• Initial Date FDA Received: 06/08/2022
• Supplement Dates Manufacturer Received: 09/20/2022
• Supplement Dates FDA Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2021
• 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