MAUDE Adverse Event Report: EBI, LLC. SPINALPAK ASSEMBLY; STIMULATOR, SPINAL PAK, NON-INVASIVE (72R ELECTRODES)

Model Number N/A

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It was reported that the patient is feeling some discomfort, like tingling, within the electrode site (neck) when wearing the device.The patient stated that she is experiencing tingling on the neck and both arms.The patient describes the sensation as feeling like electric shocks.This tingling sensation started 3 to 7 days ago.The patient feels pain when using the bone growth stimulator, but not all the time.The patient rated her pain as an 8 to a 10 on a scale of 1 to 10, which is considered severe.The pain subsided within an hour, but not completely.The patient has pain even when not using the stimulator, but it's not as bad.The patient has not increased her daily activities.The physical therapy was being performed at home, and the last day was on (b)(6) 2021.It was later reported that the doctor recommends the patient to use the spinalpak for four days consecutively, eight hours per day.It was reported that no further information is available.

Manufacturer Narrative

The device will not be returned for analysis 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.Zimmer biomet complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2021.Date of this report.Medical product: spinal pak non-invasive stimulator.Physical therapy date: (b)(6) 2021.Date received by manufacturer.Type of report.Device evaluated by manufacturer: no.Device manufacturer date.(b)(4).

Manufacturer Narrative

The device will not be returned for analysis 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.Zimmer biomet complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2021.Date of this report.Medical product: spinal pak non-invasive stimulator.Physical therapy date: (b)(6) 2021.Date received by manufacturer.Type of report.Device evaluated by manufacturer: no.Device manufacturer date.(b)(4).

Event Description

It was reported that the patient is feeling some discomfort, like tingling, within the electrode site (neck) when wearing the device.The patient stated that she is experiencing tingling on the neck and both arms.The patient describes the sensation as feeling like electric shocks.This tingling sensation started 3 to 7 days ago.The patient feels pain when using the bone growth stimulator, but not all the time.The patient rated her pain as an 8 to a 10 on a scale of 1 to 10, which is considered severe.The pain subsided within an hour, but not completely.The patient has pain even when not using the stimulator, but it's not as bad.The patient has not increased her daily activities.The physical therapy was being performed at home, and the last day was on (b)(6) 2021.It was later reported that the doctor recommends the patient to use the spinalpak for four days consecutively, eight hours per day.It was reported that no further information is available.

Manufacturer Narrative

Corrections in b4: date of the report, b5: event description, d3: manufacturer g1: contact office, g6: type of report, h2, h8 and h3.Additional information in h4: device manufacture date, h6: component, investigation type, findings, and conclusions and h10: additional narrative.This follow-up report is being submitted to relay additional and corrected information.The device was not returned to highridge medical 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.Highridge medical will continue to monitor for trend.

Event Description

It was reported that the patient is feeling some discomfort, like tingling, within the electrode site (neck) when wearing the device.The patient stated that she is experiencing tingling on the neck and both arms.The patient describes the sensation as feeling like electric shocks.This tingling sensation started 3 to 7 days ago.The patient feels pain when using the bone growth stimulator, but not all the time.The patient rated her pain as an 8 to a 10 on a scale of 1 to 10, which is considered severe.The pain subsided within an hour, but not completely.The patient has pain even when not using the stimulator, but it's not as bad.The patient has not increased her daily activities.The physical therapy was being performed at home, and the last day was on (b)(6) 2021.It was later reported that the doctor recommends the patient to use the spinalpak for four days consecutively, eight hours per day.It was reported that no further information is available.No additional patient consequences have been reported.72r electrodes were not returned for further evaluation.

• Brand Name: SPINALPAK ASSEMBLY
• Type of Device: STIMULATOR, SPINAL PAK, NON-INVASIVE (72R ELECTRODES)
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 13386028
• MDR Text Key: 285732737
• Report Number: 0002242816-2022-00006
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00812301020201
• UDI-Public: 00812301020201
• 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
• Report Date: 01/28/2022

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: 114501
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/30/2021
• Initial Date FDA Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2021
• 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
• Treatment: SEE H1 NARRATIVE.; SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic