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	Cellulitis (1768); Fever (1858); Fluid Discharge (2686)
Date of Event	11/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had her percutaneous leads removed approximately 3 weeks following their placement due to cellulitis.The patient reportedly presented at the emergency room with a high fever, and saw her implanting physician for follow-up the next day.Per the report, a pocket of fluid was noted at the exit site during the follow-up appointment and the patient experienced significant drainage after the leads were removed.The patient was reportedly prescribed antibiotics (azithromycin) for treatment of the issue following the removal of the leads.
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.The complaint report states that the patient had her percutaneous leads removed approximately 3 weeks following their placement due to cellulitis.The patient reportedly presented at the emergency room with a high fever, and saw her implanting physician for follow-up the next day.Per the report, a pocket of fluid was noted at the exit site during the follow-up appointment and the patient experienced significant drainage after the leads were removed.Per the report, the patient has a history of excessive skin sensitivity; therefore, it is possible that the issue reported in this complaint was caused or exacerbated by the patient's medical history unrelated to sprint.Note that there was no report of a culture to test for infection.The patient was reportedly prescribed antibiotics (azithromycin) for treatment of the issue following the removal of the leads.The issue reportedly resolved with no lasting effects.Per the risk file, it is considered an occasional risk that a patient may develop an infection during use of the sprint pns system that requires medical intervention or prescribed medication to treat or results in surgical intervention or extended hospitalization.If additional information becomes available regarding the resolution of the reported issues, this report will be updated.

• 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
• MDR Report Key: 16379949
• Report Number: 3011035812-2023-00001
• Device Sequence Number: 6082255
• Product Code: NHI
• UDI-Device Identifier: 00854001007557
• UDI-Public: (01)00854001007557(17)231224(10)M1140092022
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K223306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 02/13/2023

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: 12/24/2023
• Device Model Number: 9600-9288
• Device Catalogue Number: 9288-6002
• Device Lot Number: M1140092022
• 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: 02/06/2023
• Initial Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• 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: 44 YR
• Patient Sex: Female