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	Inflammation (1932); Sepsis (2067); Confusion/ Disorientation (2553); Skin Inflammation/ Irritation (4545)
Date of Event	09/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was seen at the emergency room and reported experiencing increased knee pain approximately 40 days into treatment.The patient became disoriented and bedridden in the following days.Photos were provided and appear to show swelling of the knee, as well as areas of redness and flaking skin at both lead exit sites.The patient was hospitalized and had their leads removed.The patient underwent a surgical procedure while hospitalized to clean infection from their knee.
Additional Manufacturer Narrative
A review of the device history record was performed and no anomalies were found.The patient reported experiencing increased knee pain approximately 40 days into treatment.The patient is wheelchair bound and uses a transfer board to move between their wheelchair and their bed; the patient reportedly had a "bad" transfer on the day increased pain was reported, which may have contributed to the issue.The patient was seen at the emergency room (er) on the same day and x-rays taken at the er did not show any abnormalities.The following day, the patient sounded disoriented and had slurred speech during a call with a representative.Three days after the increased knee pain was reported, the patient was still disoriented and bedridden.The patient's daughter contacted the implanting physician's office with concerns regarding the patient's condition and the patient was scheduled to have blood work done the following day.Photos taken on this day were provided and appear to show swelling of the knee, as well as areas of redness and flaking skin at both lead exit sites.The redness around one of the lead exit sites appears significantly larger in diameter and more vibrant in color than the other, and there additionally appears to be the presence of what may be dried discharge on the skin and lead at this exit site.Blood tests were performed as scheduled and results showed that the patient was septic; note that it is unclear whether a healthcare provider diagnosed the issue as sepsis, given that the test results were unavailable for complaint investigation.The patient was hospitalized and had their leads removed at the hospital and underwent a surgical procedure while hospitalized to clean infection from their knee, per follow-up with a representative in contact with the patient.No additional information regarding interventions performed at the hospital for treatment of this issue was available at the time of this investigation.If additional information regarding the patient's hospitalization becomes available, this investigation will be updated.Despite multiple attempts to obtain updates on the treatment and status of the patient from their treating physician, no additional information regarding the cause or resolution of this issue was provided.It is unclear from the information available whether the patient may have a previous medical history and/or other risk factors that increased the likelihood of experiencing an infection during stimulation treatment.Notably, the patient may have been using another medical device concurrent with sprint treatment, per a representative in contact with the patient; although the identity of this device could not be confirmed at the time of investigation, the device reportedly may have been an external catheter system.Given this uncertainty, it is unclear whether the patient's response to medical devices and/or treatments unrelated to sprint may have caused or contributed to the issue reported in this complaint (e.G., secondary to catheter-associated urinary tract infection, if it possibly occurred).

• 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
• Manufacturer Contact: kathryn stager ; 22901 millcreek blvd.; ste. 500; cleveland, OH
• MDR Report Key: 17868194
• Report Number: 3011035812-2023-00018
• Device Sequence Number: 15214286
• Product Code: NHI
• UDI-Device Identifier: 00854001007595
• UDI-Public: (01)00854001007595(17)240318(10)68957586
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 10/04/2023

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: 03/18/2024
• Device Model Number: 9600-9288
• Device Lot Number: 68957586
• 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: 09/08/2023
• Initial Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2023
• 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; Hospitalization; Other
• Patient Age: 77 YR
• Patient Sex: Female