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

Model Number N/A

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

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint# (b)(4).Date of event: the event occurred sometime in jan 2022.Medical product: unknown.Therapy date: unknown.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient has experienced discomfort within the treatment site when sitting or standing for a long time.They describes the pain as a burning sensation.The patient states that she only experiences it while she is standing.The pain is below the skin level.The patient rated her pain as a 9 on a scale of 1 to 10, which is considered severe.The patient has not increased her daily activity.The patient discontinued use until she spoke to her doctor.It was later reported that doctor recommends the patient use the spinal pack four days consecutively for sixteen hours per day.It was reported that no further information is available.

Manufacturer Narrative

Zimmer biomet complaint# (b)(4).Date of event: the event occurred sometime in (b)(6) 2022.Medical product: unknown.Therapy date: unknown.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient has experienced discomfort within the treatment site when sitting or standing for a long time.They describes the pain as a burning sensation.The patient states that she only experiences it while she is standing.The pain is below the skin level.The patient rated her pain as a 9 on a scale of 1 to 10, which is considered severe.The patient has not increased her daily activity.The patient discontinued use until she spoke to her doctor.It was later reported that doctor recommends the patient use the spinal pack four days consecutively for sixteen hours per day.It was reported that no further information is available.

Manufacturer Narrative

Corrections - b4: date of this report added, b5: updated the product was not returned for evaluation, d2: common device name, d3: manufacturer address and email address, d8: device not serviced by 3rd party, d9: device not available for evaluation, g1: contact office and manufacturer site, g6: report type, h8 additional information - d9: device not available for evaluation, h4: device manufacture date, h6: impact code, method, results, and conclusions, h10: additional narrative, h11 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 trends.

Event Description

It was reported that the patient has experienced discomfort within the treatment site when sitting or standing for a long time.They describes the pain as a burning sensation.The patient states that she only experiences it while she is standing.The pain is below the skin level.The patient rated her pain as a 9 on a scale of 1 to 10, which is considered severe.The patient has not increased her daily activity.The patient discontinued use until she spoke to her doctor.It was later reported that doctor recommends the patient use the spinal pack four days consecutively for sixteen hours per day.It was reported that no further information is available.No product was returned for 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: 13444758
• MDR Text Key: 286350375
• Report Number: 0002242816-2022-00008
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00812301020218
• UDI-Public: 00812301020218
• 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: 02/03/2022

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: N/A
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/04/2022
• Initial Date FDA Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic