MAUDE Adverse Event Report: MICRON DEVICES LLC MOVENTIS PNS; PERIPHERAL NERVE STIMULATOR

Model Number NRO4-07

Device Problems Material Erosion (1214); Improper or Incorrect Procedure or Method (2017)

Patient Problems Skin Erosion (2075); Post Operative Wound Infection (2446); Skin Infection (4544)

Event Date 12/15/2020

Event Type  Injury  

Manufacturer Narrative

The patient had a procedure performed on (b)(6) 2020 placing a pipg (nro4-07) at the superior cluneal nerve.After the procedure, the patient inquired about when she could use the hot tub, and the clinician reinforced that the patient was not use a hot tub until the incision was fully healed.The patient was instructed to apply a triple antibiotic ointment on the incision.At a follow-up appointment on (b)(6) 2020, the patient's incision site was healing and the patient reported receiving the therapy.On (b)(6) 2020, (b)(6) (field representative) was notified by the clinician that the patient presented to the doctor's office with complaints of pain at her incision site.The clinician observed the incision site showing signs of a possible infection, reportedly sore and swollen.The clinician irrigated the wound and prescribed 500 mg augmentin 1 po bidx10 days.The clinician suspected the cause of sore and swollen incision site was patient using the hot tub before the incision was fully healed.Ms.(b)(6) followed up with the patient on (b)(6) 2020, and the patient informed ms.Berry that she believed the device was possibly eroding.Ms.(b)(6) instructed the patient to return to the clinician's office immediately.The device was explanted and discarded at the clinician's office on (b)(6) 2020.It is not known if the cause of the event was device erosion or patient non-compliance with the post-procedure infection prevention measures (application of topical antibiotic ointment and avoidance of large baths of water), but both were likely contributing factors.At no time between november 9, 2020 and december 17, 2020 did the patient complain of fever or symptoms indicative of a fever.The patient reported receiving therapy while the device was implanted.The patient has expressed interest in a revision , and will coordinate with the clinician for scheduling.There was no confirmation of the infection, however the device did erode.A review of sterilization and packaging records for the respective product lot, micron confirmed that the product was delivered sterile, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.The source of the issue cannot be traced back to the device.The device did not fail to meet performance or safety specifications.The root cause of the complaint is not attributed to device failure or the inability of the device to meet performance or safety specifications.The root cause is likely attributed to the patient noncompliance with post-procedure protocols.It is possible that the device was not implanted deep enough at the time of the procedure to prevent device erosion.The implanting clinician reported that this was his first time using movent is pns.He has performed the implant procedure on additional patients, placing the device deeper in the tissue, applying bactrim during the procedure and all subsequent patients have reported wound healing and therapy.Moventis pns was not the source of the issue.

Event Description

The patient had a procedure performed on (b)(6) 2020 placing a pipg (nro4-07) at the superior cluneal nerve.After the procedure, the patient inquired about when she could use the hot tub, and the clinician reinforced that the patient was not use a hot tub until the incision was fully healed.The patient was instructed to apply a triple antibiotic ointment on the incision.At a follow-up appointment on (b)(6) 2020, the patient's incision site was healing and the patient reported receiving the therapy.On (b)(6) 2020, (b)(6) (field representative) was notified by the clinician that the patient presented to the doctor's office with complaints of pain at her incision site.The clinician observed the incision site showing signs of a possible infection, reportedly sore and swollen.The clinician irrigated the wound and prescribed 500mg augmentin 1 po bidx10 days.The clinician suspected the cause of sore and swollen incision site was patient using the hot tub before the incision was fully healed.Ms.(b)(6) followed up with the patient on (b)(6) 2020, and the patient informed ms.(b)(6) that she believed the device was possibly eroding.Ms.(b)(6) instructed the patient to return to the clinician office immediately.The device was explanted and discarded at the clinician's office on (b)(6) 2020.It is not known if the cause of the event was device erosion or patient non-compliance with the post-procedure infection prevention measures (application of topical antibiotic ointment and avoidance of large baths of water), but both were likely contributing factors.At no time between november 9, 2020 and december 17, 2020 did the patient complain of fever or symptoms indicating of a fever.The patient reported receiving therapy while the device was implanted.The patient has expressed interest in a revision, and will coordinate with the clinician for scheduling.There was no confirmation of the infection, however the device did erode.Mdr filing was initiated on (b)(6) 2021.This is the first moventis pns complaint requiring mdr filing which required the webtrader validation.The webtrader validation was completed on (b)(6) 2021 enabling the mdr report being submitted on the same day.

• Brand Name: MOVENTIS PNS
• Type of Device: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): MICRON DEVICES LLC; 606 banyan trail; boca raton FL 33431
• Manufacturer (Section G): MICRON DEVICES LLC; 606 banyan trail; boca raton FL 33431
• Manufacturer Contact: indre larson ; 606 banyan trail; boca raton, FL 33431 ; 8886910585
• MDR Report Key: 11281130
• MDR Text Key: 230687755
• Report Number: 3016547665-2021-00003
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00850017245044
• UDI-Public: (01)00850017245044(17)220701(10)200727-12150
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/07/2022
• Device Model Number: NRO4-07
• Device Lot Number: 200727-12150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2020
• 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): Other