MAUDE Adverse Event Report: NALU MEDICAL INC. TEARAWAY INTRODUCER (14CM SHEATH); SPINAL CORD STIMULATOR

Model Number	23003-060
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	08/28/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient underwent scs implant surgery on (b)(6) 2019.During the surgery the surgeon, dr.(b)(6) noticed that the patient had fluid leakage and suspected that the patient had a cerebrospinal fluid (csf) leak.The patient reported headache and dizziness symptoms post-surgery.The physician confirmed that the patient had a csf leak.While the patient was recovering from surgery, dr.(b)(6) saw the patient on (b)(6) for the scheduled post implant follow up and initial programming.Dr.(b)(6) also used this appointment to evaluate the headache and dizziness symptoms and determined that no blood patch was needed.The patient was released from the hospital on (b)(6) 2019.On (b)(6) the patient saw dr.(b)(6) for a programming follow up and to re-evaluate the patient's symptoms.The patient's issues related to the csf leak had almost completely resolved, and the patient only had minor dizziness.The patient came in for their next scheduled visit on (b)(6).At this visit the patient reported they no longer had any csf leak symptoms and are receiving great pain therapy.

• Brand Name: TEARAWAY INTRODUCER (14CM SHEATH)
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): NALU MEDICAL INC.; 2320 faraday avenue; suite 100; carlsbad CA 92008 7241
• MDR Report Key: 9119554
• Report Number: 3015425075-2019-00003
• Device Sequence Number: 2383994
• Product Code: GZB
• UDI-Device Identifier: 00812537030142
• UDI-Public: 0100812537030142111811191719111910EJ00004671
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K183047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 08/28/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/19/2019
• Device Model Number: 23003-060
• Device Catalogue Number: 23003-060
• Device Lot Number: EJ00004671
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 58 YR
• Patient Weight: 85