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

Model Number	9600-9288
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Muscle Weakness/Atrophy (1967); Numbness (2415); Ambulation or Postural Difficulties (2544)
Date of Event	08/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was disposed of, so a visual and functional evaluation could not be performed.The device history record was reviewed and no anomalies were found.There is no evidence of a device malfunction.At this time, it seems likely that removal of the leads (whether properly or improperly conducted) resulted in local swelling at the lead exit sites.Although the swelling reportedly resolved with little intervention (i.E., application of ice), other symptoms that possibly (but not conclusively) stemmed from swelling did not resolve as readily.In particular, foot drop has not been reported to resolve at the time of this investigation.Note that the physician that implanted sprint in this patient also reported during follow-up that the patient was recently diagnosed by other physicians with l3/l4 instability, for which surgery is planned.This is likely related to previous l3/l4 fusion that the patient reportedly underwent ~10 years ago; however, the implanting physician reported that it is unclear whether instability at l3/l4 caused foot drop and the cause of foot drop cannot be confirmed at this time.
Event or Problem Description
A patient that was treated for lower back pain using the sprint pns system had his percutaneous leads removed on (b)(6) 2021 according to plan (the leads are only intended to be implanted for 60 days).The physician said the leads appeared intact after removal and the patient had 50% improvement in pain.On (b)(6) 2021 the patient contacted the doctor to report 2 golf ball sized hematomas at the lead sites.The patient was instructed to apply ice.The patient contacted the doctor on (b)(6) 2021 to report that the hematomas had shrunk considerably, but that the back pain was severe and he had trouble walking.Patient also reported numbness and tingling in his feet.We were later notified that the swelling improved, but the patient has complete drop foot on right side.On (b)(6) 2021 we learned that the drop foot was not a preexisting condition.Labs ruled out infection.Mri was not as conclusive, could be osteomyelitis or degenerative changes.Foot drop is unresolved.

• Brand Name: SPRINT PNS SYSTEM
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): SPR THERAPEUTICS; 22901 millcreek blvd; suite 110; cleveland OH 44122
• MDR Report Key: 12583988
• Report Number: 3011035812-2021-00005
• Device Sequence Number: 13780252
• Product Code: NHI
• UDI-Device Identifier: 00854001007595
• UDI-Public: (01)00854001007595(17)230413(10)M1077052021
• Combination Product (Y/N): N
• PMA/510(K) Number: K202660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/05/2021

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: 04/13/2023
• Device Model Number: 9600-9288
• Device Catalogue Number: 9600-9288
• Device Lot Number: M1077052021
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 10/06/2021
• 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: Disability
• Patient Age: 77 YR