MAUDE Adverse Event Report: NALU MEDICAL INC. NALU NEUROSTIMULATION SYSTEM; SPINAL CORD STIMULATOR

Model Number	71005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	09/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted with an ipg on (b)(6) 2020.The patient's ipg and lead incisions were initially healing successfully.On (b)(6) 2020 patient completed oral antibiotics for a non-related medical infection.Then on (b)(6) 2020 the patient was referred to the emergency room to receive iv antibiotics for the same non-related infection.Patient reported the incision site showed delayed healing and signs of infection as well.As of (b)(6) 2020, the infection had subsided and wound was healing.

• Brand Name: NALU NEUROSTIMULATION SYSTEM
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): NALU MEDICAL INC.; 2320 faraday avenue; suite 100; carlsbad CA 92008 7241
• MDR Report Key: 10954149
• Report Number: 3015425075-2020-00012
• Device Sequence Number: 16688788
• Product Code: GZB
• UDI-Device Identifier: 00812537030975
• UDI-Public: 01008125370309751119111417201113
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K183047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2020

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: Health Professional
• Device Expiration Date: 11/13/2020
• Device Model Number: 71005
• Device Catalogue Number: 71005
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 12/05/2020
• 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: Other
• Patient Age: 46 YR