MAUDE Adverse Event Report: EBI, LLC. SPINALPAK ASSEMBLY; STIMULATOR, SPINALPAK, NONIVASIVE

Model Number N/A

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

Patient Problem Pain (1994)

Event Date 08/11/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Date of event: (b)(6) 2021 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 by the sales rep that they gave (b)(6) his spak on tuesday (b)(6) 2021 and he said by wednesday he was having significant pain.When he removed the pads two days later to change the positioning he got relief.Then the pain came back and persisted until he took the stim off yesterday (sunday (b)(6) 2021).I advised he continue to keep it off until thursday and put it back on for an hour only.Then try 2 hours the following day.He is comfortable trying this.Called the patient.Left a message to call back regarding pain while wearing the unit.I received a call back from the patient who stated that the pain was below the surface of the skin the right side of the body was throbbing.The pain level was a ten.The patient stated that the pain started last tuesday as soon as he started treating with the spak through sunday when he took it off.The pain went away within 10 minutes of taking off the stimulator.The patient stated that he had experienced this pain before from neuropathy.The pain was under control until he used the spak.Daily activities decreased while using the unit.The patient called his doctor who referred him to sales rep.The patient's pain level is about a 4 or 5 right now.The patient will start doing the time test on thursday.

Manufacturer Narrative

This follow-up report is being submitted to relay additional.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 was reviewed and no discrepancies related to the reported event were found.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.H3: device evaluated by manufacturer updated to no.H6: device code updated to 2993: adverse event without identified device or use problem.H6: investigation code updated to 4114: device not returned.H6: investigation code updated to 4119: insufficient information available.H6: investigation code updated to 3331 - analysis of production records.H6: investigation findings code updated to 3221: no findings available.H6: investigation conclusions code updated to 4315: cause not established.H10: additional narratives/data.

Event Description

It was reported by the sales rep that they gave (b)(6) his spak on tuesday 8/10 and he said by wednesday he was having significant pain.When he removed the pads two days later to change the positioning he got relief.Then the pain came back and persisted until he took the stim off yesterday (sunday 8/15).I advised he continue to keep it off until thursday and put it back on for an hour only.Then try 2 hours the following day.He is comfortable trying this.Called the patient.Left a message to call back regarding pain while wearing the unit.I received a call back from the patient who stated that the pain was below the surface of the skin the right side of the body was throbbing.The pain level was a ten.The patient stated that the pain started last tuesday as soon as he started treating with the spak through sunday when he took it off.The pain went away within 10 minutes of taking off the stimulator.The patient stated that he had experienced this pain before from neuropathy.The pain was under control until he used the spak.Daily activities decreased while using the unit.The patient called his doctor who referred him to sales rep.The patient's pain level is about a 4 or 5 right now.The patient will start doing the time test on thursday.

• Brand Name: SPINALPAK ASSEMBLY
• Type of Device: STIMULATOR, SPINALPAK, NONIVASIVE
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• MDR Report Key: 12466429
• MDR Text Key: 271228017
• Report Number: 0002242816-2021-00165
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00812301020218
• UDI-Public: 00812301020218
• Combination Product (y/n): N
• PMA/PMN Number: P850022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

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: 08/17/2021
• Initial Date FDA Received: 09/14/2021
• Supplement Dates Manufacturer Received: 08/17/2021
• Supplement Dates FDA Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention