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

Model Number	N/A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The event occurred sometime in (b)(6) 2019.Concomitant medical products: medical product: c5-6 and c6-7 titanium cages and anterior plate; therapy date: 2012.The customer has indicated that the product is in the process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Device has not been returned.
Event or Problem Description
It was reported that the spinalpak stimulator was causing the patient's heart rate to increase.The patient stated that his heart rate increased to over 100 and would only reach that level when he was wearing the spinalpak stimulator.He reached out to his cardiologist and the ordering doctor to discuss his symptoms and both advised him to stop using the unit.No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow up report is being submitted to relay additional information.The device was returned to zimmer biomet for investigation.No physical and/or device functional condition could be found that could be considered a causal factor for the reported complaint.The device operated/functioned as intended.The device history record (dhr) was reviewed and no discrepancies were found.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: h3: device evaluated by manufacturer updated to yes.H6: method code updated to 3331: analysis of production records.H6: method code updated to 10: testing of actual/suspected device.H6: results code updated to 213: no device problem found.H6: conclusions code updated to 4315: cause not established.
Event or Problem Description
It was reported that the spinalpak stimulator was causing the patient's heart rate to increase.The patient stated that his heart rate increased to over 100 and would only reach that level when he was wearing the spinalpak stimulator.He reached out to his cardiologist and the ordering doctor to discuss his symptoms and both advised him to stop using the unit.No additional patient consequences were reported.

• Brand Name: SPINALPAK STIMULATOR, BIOMET
• Common Device Name: STIMULATOR, BONE GROWTH, NON-INVASIVE
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• MDR Report Key: 9218004
• Report Number: 0002242816-2019-00032
• Device Sequence Number: 11472253
• Product Code: LOF
• UDI-Device Identifier: 00812301020225
• UDI-Public: 00812301020225
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P850022
• 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): 01/31/2020

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: 1067717
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 01/31/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 98