MAUDE Adverse Event Report: SPR THERAPEUTICS SPRINT PNS SYSTEM; PERIPHERAL NERVE STIMULATOR

Model Number	ENDURA, SALES CONFIGURATION
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Paralysis (1997); Paresis (1998); Urinary Retention (2119); Limb Pain (4836)
Date of Event	03/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A single lead was placed on (b)(6) 2023, targeting the right side at l5 medial branch of the dorsal ramus.The patient reported that she had difficulty walking that started after she returned home from the procedure.On (b)(6) 23, the patient contacted the implanting physician and reported that she cannot walk, and her baseline pain is now radiating to the left side.The patient was also experiencing some urinary retention, noting only dribbling, not a strong stream.
Additional Manufacturer Narrative
The patient stated that she felt increased pain in her leg following the lead placement, and the treating team reportedly attributed this to normal discomfort following the procedure.The patient reportedly experienced pain in her contralateral leg on the day after lead placement and stated that she could not move either of her legs.Per the patient, this issue occurred regardless of whether stimulation was turned on or off.The patient also expressed difficulty urinating around this time, but the issue reportedly resolved approximately an hour later.The patient was seen by their implanting physician on the day after lead placement for assessment.The patient reportedly demonstrated that she could move her left leg during this visit but did not demonstrate moving her right leg due to significant pain she reportedly experienced at the time.The patient's lead was removed intact, according to a representative present at the visit.Per this representative, the patient's physician did not assess whether the issues experienced by the patient were device-related.The patient was taken from the visit to the emergency room (er).It was reported that a magnetic resonance imaging (mri) with contrast showed evidence of inflammation but did not show evidence of hematoma.The patient reportedly was not admitted to the hospital and was discharged from the er on the same day.The patient, who normally had trouble with walking prior to beginning sprint treatment, reportedly experienced a return to her baseline level of mobility by the time a representative followed-up with her 12 days after the lead placement procedure.Per correspondence with a medical advisor, the issue in this complaint may have been caused by a transient nerve root injury from the lead placement procedure.According to the risk file, the stimulating probe or microlead introducer may puncture a nerve, blood vessel, joint space, or visceral organ during the lead placement procedure; the risk that this results in minor damage that is not detectable at the time of the procedure is considered occasional and the risk that this results in serious or critical damage (e.G., paralysis) is considered remote.Reported rates of nerve damage for related procedures (e.G., peripheral nerve blocks targeting various nerves) are low (0.015%-0.046%).Note that the clinician instructions for use advises the user to use imaging (e.G., ultrasound or fluoroscopic guidance) to guide placement of the microlead or stimulating probe.Given that the patient has a history of difficulty with walking, it is also possible that the issue reported in this complaint may have been associated the patient's pre-existing medical history unrelated to sprint.Since the patient's issues reportedly occurred regardless of whether stimulation was turned on or off, it is unlikely that the issues were related to stimulation treatment.The patient's external pulse generator (epg) and rechargeable battery were returned and inspected.The epg operated correctly and there was no evidence of a product malfunction; a total of 6 hours of usage was logged by the device.Therefore, it is not suspected that the sprint product was faulty or had any specific deficiency based on the information available in this report.
Additional Manufacturer Narrative
Additional product was returned for investigation (microlead and connector) and there was no evidence of a product malfunction.

• Brand Name: SPRINT PNS SYSTEM
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): SPR THERAPEUTICS; 22901 millcreek blvd.; ste 500; cleveland
• Manufacturer (Section G): SPR THERAPEUTICS; 22901 millcreek blvd.; ste 500; cleveland OH 44122
• Manufacturer Contact: kathryn stager ; 22901 millcreek blvd.; ste 500; cleveland, OH 44122
• MDR Report Key: 16702699
• Report Number: 3011035812-2023-00006
• Device Sequence Number: 14882969
• Product Code: NHI
• UDI-Device Identifier: 00854001007540
• UDI-Public: (01)00854001007540(17)240326(10)M1028122022
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K223306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023

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: 03/26/2024
• Device Model Number: ENDURA, SALES CONFIGURATION
• Device Catalogue Number: 93244-6001
• Device Lot Number: M1028122022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR
• Patient Sex: Female