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

Model Number	Extensa, Shipping Configuration
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930); Subcutaneous Nodule (4548)
Date of Event	03/18/2022
Type of Reportable Event	Serious Injury
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.During examination, the exit site reportedly felt hard when palpated but there were no visible signs of infection.Per the complaint description and follow-up with a representative in contact with the patient, the leads were removed as a precaution during this visit, after eight weeks of treatment.The leads reportedly appeared intact upon removal, without any sign of purulent discharge.The patient's physician reportedly applied neosporin to a bandage that was applied to the exit site following lead removal.The patient reportedly experienced fever and chills beginning the day after lead removal and was admitted to the hospital two days after lead removal.Per follow-up with the patient, an infection in the tissue near the lead exit site was reportedly confirmed; a procedure was completed to remove the infected muscle tissue, a drain was placed at the affected site, and the patient began a 14-day course of iv antibiotics.Additional information on the resolution of the issues described in this complaint was unavailable at the time of investigation.Per follow-up communications, the patient has a pre-existing history of rheumatoid arthritis (ra) that was treated with immunosuppressive medications; intake of these medications was reportedly stopped prior to the lead placement procedure, but the patient resumed taking immunosuppressive medications approximately 1 month after lead placement.The identities and dosages of these medications were not specified.Although it is possible that the percutaneous nature of the sprint pns system contributed to the issues reported in this complaint, it is also probable that the consumption of immunosuppressive medications before and during sprint treatment (for treatment of pre-existing ra unrelated to sprint) may have increased the patient's risk of infection at the lead exit site.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 surgical intervention or extended hospitalization.If additional information becomes available regarding the resolution of the reported issues, this report will be updated.
Event or Problem Description
Patient called regional sales manager (rsm) wanting to have her leads removed.Patient stated that she felt like she had a infection.Patient made an appointment to see her doctor and the rsm met with them.The decision was made to pull the lead.There was no visible infection but the doctor made the decision because the area where the lead was felt " hard" and the patient was close to the end of therapy.The rsm got a call from the doctor that the patient was going to be admitted and have surgery to remove the "infected area " per the doctor.Patient is in the hospital with a drain.Per rsm, there was no sign of infection on a surface level where the lead was inserted but underneath the skin there was a infection.

• Brand Name: SPRINT
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): SPR THERAPEUTICS; 22901 millcreek blvd; ste 110; cleveland OH 44122
• Manufacturer (Section G): SPR THERAPEUTICS; 22901 millcreek blvd; ste 110; cleveland OH 44122
• Manufacturer Contact: kathryn stager ; 22901 millcreek blvd; ste 110; cleveland, OH 44122 ; 2163789067
• MDR Report Key: 14112362
• Report Number: 3011035812-2022-00001
• Device Sequence Number: 2148467
• Product Code: NHI
• UDI-Device Identifier: 00854001007595
• UDI-Public: (01)00854001007595(17)230607(10)M1005082021
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K202660
• 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): 04/14/2022

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: 06/07/2023
• Device Model Number: Extensa, Shipping Configuration
• Device Catalogue Number: 9600-9288
• Device Lot Number: M1005082021
• 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: 03/18/2022
• Initial Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• 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; Life Threatening
• Patient Age: 46 YR
• Patient Sex: Female