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

Model Number 71005

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Date 09/14/2020

Event Type  Injury  

Event 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
• 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 ; 7604482360
• MDR Report Key: 10954149
• MDR Text Key: 219876912
• Report Number: 3015425075-2020-00012
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537030975
• UDI-Public: 01008125370309751119111417201113
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 12/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2019
• 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): Other
• Patient Age: 46 YR