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

Model Number	9244-6001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Skin Inflammation/ Irritation (4545)
Date of Event	09/23/2024
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's lead was removed prior to the planned end of treatment date (eight days after implant) due to a suspected allergic reaction.Per follow-up with a representative in contact with the patient, the patient reportedly developed a skin rash four days after their lead was implanted.The patient reported experiencing a variety of additional symptoms including extreme itchiness, yellow-tinted discharge from the lead exit site, tongue tingling, throat tightness, and fatigue in association with the reported issue.The patient reportedly presented at the emergency department (ed) for assessment of the issue at which time a soft tissue ultrasound and culture of the lead exit site discharge were performed; however, results of this testing were not available at the time of investigation.The patient was reportedly prescribed an antibiotic for treatment of the issue at the time of the initial ed visit.The patient's symptoms reportedly persisted in the days following the initial ed visit, and the patient was directed back to the ed by their implanting physician to have their lead removed.During the second ed visit, the patient was reportedly administered diphenhydramine (benadryl) and intravenous (iv) fluids.The patient was reportedly discharged from the ed following removal of the lead and provided a prescription steroid cream for further treatment of the skin rash.The ed physicians that examined the patient during both visits reportedly believed the issue may have been bandaging related, but also believed the symptoms experienced were in association with a foreign body reaction to the implant.The patient was reportedly recommended to visit an allergist before receiving any other pain interventions due to a history of anaphylactic reactions, per follow-up with a representative in contact with the patient.The patient reported feeling better almost immediately after the removal of the lead; however, the patient was reportedly still experiencing a rash and open sores from scratching the affected area in the weeks following lead removal, per an update provided by a representative in contact with the patient.If additional information regarding resolution of the issue becomes available, this investigation will be updated.
Event or Problem Description
The patient reported allergic reaction requiring emergency department provider to remove lead.

• Brand Name: SPRINT
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): SPR THERAPEUTICS; 22901 millcreek blvd.; suite 500; cleveland OH 44122
• Manufacturer (Section G): SPR THERAPEUTICS; 22901 millcreek blvd.; suite 500; cleveland OH 44122
• Manufacturer Contact: kathryn stager ; 22901 millcreek blvd.; suite 500; cleveland, OH 44122 ; 2163789067
• MDR Report Key: 20523903
• Report Number: 3011035812-2024-00008
• Device Sequence Number: 7969389
• Product Code: NHI
• UDI-Device Identifier: 00854001007540
• UDI-Public: (01)00854001007540(17)250706(10)75298061
• Combination Product (Y/N): N
• PMA/510(K) Number: K223306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 10/24/2024

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: 07/06/2025
• Device Model Number: 9244-6001
• Device Lot Number: 75298061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2024
• 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
• Patient Age: 64 YR
• Patient Sex: Female