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); Inflammation (1932); Ambulation or Postural Difficulties (2544); Fluid Discharge (2686)
Date of Event	02/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported experiencing pain behind their knee and fluid drainage from their lead exit sites beginning two days after the leads were placed.Per follow-up with a representative in contact with the patient, the patient reported severe pain, redness, swelling, continued drainage, and the inability to bend their leg/walk the following day (i.E., 3 days after lead placement) and went to the emergency room for evaluation.A photo was provided that appears to show the bandage partially saturated with brown-tinted fluid, as well as redness of the skin surrounding both of the lead exit sites and extending past the edge of the bandage.Both of the patient's leads were reportedly removed intact at the emergency room.The patient was reportedly started on two types of iv antibiotics (type, frequency, and dosage unknown) and admitted to the hospital.The patient reported experiencing continued and increased swelling and redness of the affected area for at least two of the following days; photos were provided that appear to show dated boundary lines on the patient's leg indicating the spread of redness in the days following the patient's admission to the hospital.A ct with contrast was performed at the emergency room and revealed likely superficial cellulitis, per the patient's implanting physician.
Additional Manufacturer Narrative
A review of the device history record was performed and no anomalies were found.The complaint states that the patient reported experiencing pain behind their knee and fluid drainage from their lead exit sites beginning two days after the leads were placed.Per follow-up with a representative in contact with the patient, the patient reported severe pain, redness, swelling, continued drainage, and the inability to bend their leg/walk the following day (i.E., 3 days after lead placement) and went to the emergency room for evaluation.A photo was provided that appears to show the bandage partially saturated with brown-tinted fluid, as well as redness of the skin surrounding both of the lead exit sites and extending past the edge of the bandage.Both of the patient's leads were reportedly removed intact at the emergency room.The patient was reportedly started on two types of iv antibiotics (type, frequency, and dosage unknown) and admitted to the hospital.The patient reported experiencing continued and increased swelling and redness of the affected area for at least two of the following days; photos were provided that appear to show dated boundary lines on the patient's leg indicating the spread of redness in the days following the patient's admission to the hospital, consistent with the patient's report.A ct with contrast was performed at the emergency room and revealed likely superficial cellulitis, per the patient's implanting physician.The leads, as well as fluid from the exit sites, were sent for culture; the cultures reportedly grew streptococcus pyogenes.The patient additionally reported receiving an oral streptococcus test in the hospital that had a negative result.Per a representative present for the lead implant procedure, the sterile field may have been disrupted during the procedure by the patient reaching their hand over the sterile field; if this occurred, it is possible that disruption of the sterile field may have contributed to the issue reported in this complaint.Per follow-up with a representative in contact with the patient, the patient was discharged from the hospital four days after admission.The patient was reportedly given oral antibiotics to continue treatment of the issue and referred to a specialist for their difficulty walking.Per an update provided by a representative in contact with the patient, the patient's difficulty walking subsided following their discharge from the hospital.The infection reportedly had not resolved at the time of the update.If any additional information becomes available regarding clarification of the reported issues or the resolution of the reported issues, this investigation 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; suite 500; cleveland 44122
• MDR Report Key: 16582140
• Report Number: 3011035812-2023-00004
• Device Sequence Number: 19228276
• Product Code: NHI
• UDI-Device Identifier: 00854001007557
• UDI-Public: (01)00854001007557(17)231101(10)M1172092022
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/21/2023

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: 11/01/2023
• Device Model Number: 9600-9288
• Device Catalogue Number: 9288-6002
• Device Lot Number: M1172092022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2023
• Initial Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2022
• 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; Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Race: White