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

Model Number	9600-9288
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Fluid Discharge (2686); Skin Infection (4544)
Date of Event	04/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record was performed and no anomalies were found.The complaint reports that the patient experienced redness surrounding their lead exit sites beginning 12 days after the leads were implanted, as well as serous fluid drainage from the exit sites beginning approximately one month after the leads were implanted.Photos attached to the complaint appear to show redness directly surrounding both lead exit sites, as well as what appears to be dried surgical glue (i.E., dermabond) on top of at least one of the lead exit sites.The patient was reportedly seen by their physician in-clinic following the onset of serous fluid drainage; the patient's physician reportedly suspected the issue could be due to infection or allergic reaction to dermabond, the lead materials, or the patient's knee replacement hardware, per the complaint report and follow-up with a representative in contact with the patient.The patient was reportedly prescribed antibiotics and referred to an allergist for further assessment of the issue.Note that there was no report of a culture to test for infection, or additional information regarding an allergist's assessment of the issue available at the time of investigation.Due to the proximity of the suspectied infection to hardware from the patient's surgically repaired knee and considering that intervention was required to prevent further injury, this event is considered a serious inury.Per the complaint report, the patient has a history of foreign body reactions to medical implants not related to sprint (e.G., an intrauterine device) and the patient's physician suspected the issue reported in this complaint could be related to the patient's knee replacement hardware; therefore, it is possible that a predisposition for increased sensitivity to foreign body reaction and/or a reaction to a different foreign body (e.G., the patient's knee replacement implant) may have caused or exacerbated the reported issue.The patient reported decreased redness and drainage, per a representative in contact with the patient, and was able to complete sprint treatment without interruption, no lasting effects are anticipated.
Event or Problem Description
The complaint reports that the patient experienced redness surrounding their lead exit sites beginning 12 days after the leads were implanted, as well as serous fluid drainage from the exit sites beginning approximately one month after the leads were implanted.The patient was prescribed bactrim for treatment of the issue.

• Brand Name: SPRINT
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): SPR THERAPEUTICS; 22901 millcreek blvd.; ste. 500; cleveland OH 44122
• 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 ; 2163789067
• MDR Report Key: 17045742
• Report Number: 3011035812-2023-00010
• Device Sequence Number: 14734976
• Product Code: NHI
• UDI-Device Identifier: 00854001007595
• UDI-Public: (01)00854001007595(17)240601(10)M1010022023
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2023

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: 06/01/2024
• Device Model Number: 9600-9288
• Device Catalogue Number: 9600-9288
• Device Lot Number: M1010022023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2023
• 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: Required Intervention; Other
• Patient Age: 69 YR
• Patient Sex: Female