MAUDE Adverse Event Report: EBI, LLC. ELECTRODES, LT-4500

Model Number	N/A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Itching Sensation (1943); Skin Irritation (2076)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical product: spinalpak assembly - catalog #1067716 serial # (b)(4).Therapy date: unknown.The customer has indicated that the product will not be returned to zimmer biomet for investigation because the patient used all of the electrodes.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002242816-2019-00040.Device has not been returned.
Event or Problem Description
It was reported that the patient was experiencing skin irritation from using the 72r electrodes with the spinalpak unit.The patient stated that her skin was very itchy and it made it difficult to sleep at night.The patient tried using the lt-4500 electrodes which caused an irritation on her skin as well.The patient contacted her doctor who advised her to discontinue using the spinalpak unit.No additional patient consequences were reported.
Additional Manufacturer Narrative
This report is being submitted to relay additional information.The device was not returned to zimmer biomet for evaluation.The reported event was unable to be confirmed due to limited information received from the customer.The device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.The following sections were updated: b4: date of this report added.G4: date received by manufacturer added.G7: type of report.H2: follow up type.H3: device evaluated by manufacturer updated to no.H6: method code updated to 4114: device not returned.H6: results code updated to 3221: no findings available.H6: conclusions code updated to 4315: cause not established.H10: additional narratives/data h3 other text : the device has not been returned.
Event or Problem Description
It was reported that the patient was experiencing skin irritation from using the 72r electrodes with the spinalpak unit.The patient stated that her skin was very itchy and it made it difficult to sleep at night.The patient tried using the lt-4500 electrodes which caused an irritation on her skin as well.The patient contacted her doctor who advised her to discontinue using the spinalpak unit.No additional patient consequences were reported.

• Brand Name: ELECTRODES, LT-4500
• Common Device Name: ELECTRODES
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• MDR Report Key: 9413004
• Report Number: 0002242816-2019-00042
• Device Sequence Number: 19409655
• Product Code: LOF
• UDI-Device Identifier: 00812301020188
• UDI-Public: 00812301020188
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P850022/S017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 106130-12
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 01/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention