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

Model Number 71004

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

Patient Problem Impaired Healing (2378)

Event Date 09/27/2020

Event Type  Injury  

Event Description

Patient was implanted on (b)(6) 2020.The patient's ipg incision showed delayed healing and signs of irritation.The patient was prescribed oral antibiotics for what was believed to be an infection.On (b)(6) 2020 it was evident the internal sutures at the incision site were dislodging.The internal sutures were removed on (b)(6) 2020 and replaced with a tegaderm over the area.

• 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: 10667343
• MDR Text Key: 211026492
• Report Number: 3015425075-2020-00013
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537033594
• UDI-Public: 01008125370335941120060917210609
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2021
• Device Model Number: 71004
• Device Catalogue Number: 71004
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2020
• 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): Required Intervention
• Patient Age: 88 YR