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

Model Number 23003-060

Device Problem Use of Device Problem (1670)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 08/28/2019

Event Type  Injury  

Event 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)
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): NALU MEDICAL INC.; 2320 faraday avenue; suite 100; carlsbad CA 92008 7241
• Manufacturer (Section G): NALU MEDICAL INC.; 2320 faraday avenue; suite 100; carlsbad CA 92008 7241
• Manufacturer Contact: terry villarba ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7608276463
• MDR Report Key: 9119554
• MDR Text Key: 163811216
• Report Number: 3015425075-2019-00003
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537030142
• UDI-Public: 0100812537030142111811191719111910EJ00004671
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K183047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR
• Patient Weight: 85