MAUDE Adverse Event Report: EBI, LLC. BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM; STIMULATOR, BONE GROWTH, NON-INVASIVE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Chest Pain (1776)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported the patient was using the device to treat her cervical area and she was treating with the device for 24 hours a day.She stated she experienced pain in her heart while using the device, when she took it off the pain went away.She also took aspirin and that lessened the pain.She states she has atrial fibrillation (afib) and it is not unusual for her to wake up with chest pains, however she stated this is not like the pain she experienced while using the device.She states the pain felt like a cramping in her heart.She wore the device for four days and has not treated with it since.She shared her experience with two of her doctors; no treatment was provided.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.No fail condition was found after the investigation associated with pain.Visual inspection to the sp unit, charger, ac adapter, both batteries and both lead wires confirms that no exposed wiring was observed.Further review of other component received as sp unit, charger, ac adapter, both cable assemblies and two (2) batteries confirmed they operated/function as intended specifically the sp unit run burn-in for 56 hours with no problem.No abnormal condition could be identified during the investigation and device evaluation that could be considered causal factor for the reported condition.Device history record (dhr) was reviewed and no discrepancies were found.Device analysis indicated that the device met specification.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM
• Type of Device: STIMULATOR, BONE GROWTH, NON-INVASIVE
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• MDR Report Key: 7293723
• MDR Text Key: 100841890
• Report Number: 0002242816-2018-00004
• Device Sequence Number: 1
• Product Code: LOF
• Combination Product (y/n): N
• PMA/PMN Number: PP850022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• 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
• Other Device ID Number: (01) 0 0812301 02021 8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Date Manufacturer Received: 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other